Regulatory Open Forum

Hi members,

Recently, I have obtained a RAC certificate (Dual) with an intention of career transition. In spite of numerous application, I have not received single response. I have tried in positions where prior experience not required but no response. It seems, in this profession "no experience-----no job". I will appreciate if you can provide me any advice. I have a background in bio-medical research and reviewer for IRB. Thanks in advance for any form of assistance.

Regards,
Nupur 


-------------------------------------------
Nupur Gangopadhyay D.V.M, M.S.,Ph.D, RAC
Monroeville PA
United States
-------------------------------------------

Hello Nupur

At first glance, I would say that all your professional credentials might be a deterrent to getting a response.  Hiring managers may be asking why a DVM,/PhD would want an entry level regulatory position.  Additionally they might be concerned that you would expect far more compensation than what they are willing to pay.

So although it sounds counter-intuitive, you may want to downplay some of your credentials (at lease upfront) in your cover letter and resume, and concentrate on the reasons that you are interested in an entry level regulatory affairs position and what makes you a great candidate.

Good luck!  Lauren

-------------------------------------------
Lauren Kamer, MS Pharm, RAC
-------------------------------------------


Original Message:
Sent: 10-21-2014 18:54
From: Nupur Gangopadhyay
Subject: How to find a entry level regulatory job

Hi members,

Recently, I have obtained a RAC certificate (Dual) with an intention of career transition. In spite of numerous application, I have not received single response. I have tried in positions where prior experience not required but no response. It seems, in this profession "no experience-----no job". I will appreciate if you can provide me any advice. I have a background in bio-medical research and reviewer for IRB. Thanks in advance for any form of assistance.

Regards,
Nupur 


-------------------------------------------
Nupur Gangopadhyay D.V.M, M.S.,Ph.D, RAC
Monroeville PA
United States
-------------------------------------------

Hi Lauren,

Thanks for your advice and suggestion.I completely agree with your opinion on my resume and cover letter.

Regards,
Nupur

 
-------------------------------------------
Nupur Gangopadhyay PHD
Monroeville PA
United States
-------------------------------------------


Original Message:
Sent: 10-22-2014 08:10
From: Lauren Kamer
Subject: How to find a entry level regulatory job

Hello Nupur

At first glance, I would say that all your professional credentials might be a deterrent to getting a response.  Hiring managers may be asking why a DVM,/PhD would want an entry level regulatory position.  Additionally they might be concerned that you would expect far more compensation than what they are willing to pay.

So although it sounds counter-intuitive, you may want to downplay some of your credentials (at lease upfront) in your cover letter and resume, and concentrate on the reasons that you are interested in an entry level regulatory affairs position and what makes you a great candidate.

Good luck!  Lauren

-------------------------------------------
Lauren Kamer, MS Pharm, RAC
-------------------------------------------


Original Message:
Sent: 10-21-2014 18:54
From: Nupur Gangopadhyay
Subject: How to find a entry level regulatory job

Hi members,

Recently, I have obtained a RAC certificate (Dual) with an intention of career transition. In spite of numerous application, I have not received single response. I have tried in positions where prior experience not required but no response. It seems, in this profession "no experience-----no job". I will appreciate if you can provide me any advice. I have a background in bio-medical research and reviewer for IRB. Thanks in advance for any form of assistance.

Regards,
Nupur 


-------------------------------------------
Nupur Gangopadhyay D.V.M, M.S.,Ph.D, RAC
Monroeville PA
United States
-------------------------------------------

Hi Nupur,

What I have seen is many of the people around me had jobs in industry prior to transitioning to Regulatory. At my company we have Reg CMC, and Reg Clin/Non-Clin, etc., so for me I was able to utilize my previous experience toward the transition into Regulatory. 

Also, I wanted to know if you actually took the certificate courses (certificate) or took the test and became RAC certified. To me they are two different and distinct things. Reading your email, it seems like you took the certificate program, and have not taken the test. I could be wrong, but that is how I read it.

Also, I have not seen your resume, but as a hiring manager, I would look at your resume to see what type of regulatory work you did. Even if you were a preclinical scientist, you must have generated reports and IND/NDA/BLA sections of submissions for various compounds. Those would be a good starting point for you.

Good luck on your search. And just keep looking.
-------------------------------------------
Albert Wong
Manager, Regulatory CMC
Biomarin Pharmaceutical Inc.
San Francisco CA
United States
-------------------------------------------


Original Message:
Sent: 10-21-2014 18:54
From: Nupur Gangopadhyay
Subject: How to find a entry level regulatory job

Hi members,

Recently, I have obtained a RAC certificate (Dual) with an intention of career transition. In spite of numerous application, I have not received single response. I have tried in positions where prior experience not required but no response. It seems, in this profession "no experience-----no job". I will appreciate if you can provide me any advice. I have a background in bio-medical research and reviewer for IRB. Thanks in advance for any form of assistance.

Regards,
Nupur 


-------------------------------------------
Nupur Gangopadhyay D.V.M, M.S.,Ph.D, RAC
Monroeville PA
United States
-------------------------------------------

Hi Albert,

Thanks for your comments. I think obtaining education in school is a better place as you can interact with other students, faculties, and chance of having an apprenticeship which paves your way for a career. In most of the professions, job opening structure is like a Pyramid scaffold where ample of entry level jobs are available. Like in the case of biomedical Ph.D., a post doctoral fellowship already available before you earns your degree. Such example applies to engineering etc. I am not sure whether an apprentice is available in this profession. Because, RA does not require a laboratory or engineering facility, probably candidates can learn necessary process remotely. I completely understand that each profession might have a unique situation as regulatory affairs one. Probably, RA is little bit more difficult profession as a lion share of the jobs are in private sector where an employer does not want to spend a single penny for train a new personnel rather hire someone already doing same kind of job. I am not complaining, being new in this profession, just trying to learn uniqueness of the RA profession.

In my case, I have extensive experience in IRB, clinical protocol, medical writing, and basic science research but those experiences are probably categorized as secondary/desirable qualifications as most of the employers are looking for a person with IND/NDA/BLA related experience. I completely agree with Lauren about my qualifications which are killing my candidature. It is hard to convince anyone that based on my former experience; I need very little training period to learn IND/NDA/BLA related filing. I will appreciate if you could spare couple of moments to have a look into my resume attached in initial blog.  

Once again my sincere thanks for your suggestions.

With regards,

 Nupur

-------------------------------------------
Nupur Gangopadhyay Ph.D., RAC
Monroeville PA
United States
-------------------------------------------


Original Message:
Sent: 10-25-2014 02:06
From: Albert Wong
Subject: How to find a entry level regulatory job

Hi Nupur,

What I have seen is many of the people around me had jobs in industry prior to transitioning to Regulatory. At my company we have Reg CMC, and Reg Clin/Non-Clin, etc., so for me I was able to utilize my previous experience toward the transition into Regulatory. 

Also, I wanted to know if you actually took the certificate courses (certificate) or took the test and became RAC certified. To me they are two different and distinct things. Reading your email, it seems like you took the certificate program, and have not taken the test. I could be wrong, but that is how I read it.

Also, I have not seen your resume, but as a hiring manager, I would look at your resume to see what type of regulatory work you did. Even if you were a preclinical scientist, you must have generated reports and IND/NDA/BLA sections of submissions for various compounds. Those would be a good starting point for you.

Good luck on your search. And just keep looking.
-------------------------------------------
Albert Wong
Manager, Regulatory CMC
Biomarin Pharmaceutical Inc.
San Francisco CA
United States
-------------------------------------------


Original Message:
Sent: 10-21-2014 18:54
From: Nupur Gangopadhyay
Subject: How to find a entry level regulatory job

Hi members,

Recently, I have obtained a RAC certificate (Dual) with an intention of career transition. In spite of numerous application, I have not received single response. I have tried in positions where prior experience not required but no response. It seems, in this profession "no experience-----no job". I will appreciate if you can provide me any advice. I have a background in bio-medical research and reviewer for IRB. Thanks in advance for any form of assistance.

Regards,
Nupur 


-------------------------------------------
Nupur Gangopadhyay D.V.M, M.S.,Ph.D, RAC
Monroeville PA
United States
-------------------------------------------

Nupur,

I just wanted to follow up on one thing that I think Albert was bringing to your attention. You list yourself as having the RAC credential, but you description makes it sound like you are doing so after taking the certificate courses. It's a fully understandable confusion, but those courses have nothing to do with the RAC credential. That credential is earned by taking and passing the Regulatory Affairs Certification (RAC) Exam, either for US, EU, Canadian, or Global regulatory affairs. If you are listing yourself on your resume as an RAC and have not passed that exam, that should probably be changed. RAPS maintains a public list of RAC holders, so any company could easily check and see that you aren't one, which would at least give me pause when reviewing an application.

Good luck in your job search!

-------------------------------------------
Steven Lawrie, MS, MA
Regulatory Affairs Team Lead
Cook, Inc.
Bloomington IN
-------------------------------------------



Original Message:
Sent: 10/25/2014 9:52:57 PM
From: nupurnikkan@gmail.com
Subject: RE: How to find a entry level regulatory job

Hi Albert, Thanks for your comments. I think obtaining education in school is a better place as you can interact with other students, faculties, and chance of having an apprenticeship which paves your way for a career. In most of the professions, job opening structure is like a Pyramid scaffold where ample of entry level jobs are available. Like in the case of biomedical Ph.D., a post doctoral fellowship already available before you earns your degree. Such example applies to engineering etc. I am not sure whether an apprentice is available in this profession. Because, RA does not require a laboratory or engineering facility, probably candidates can learn necessary process remotely. I completely understand that each profession might have a unique situation as regulatory affairs one. Probably, RA is little bit more difficult profession as a lion share of the jobs are in private sector where an employer does not want to spend a single penny for train a new personnel rather hire someone already doing same kind of job. I am not complaining, being new in this profession, just trying to learn uniqueness of the RA profession.

In my case, I have extensive experience in IRB, clinical protocol, medical writing, and basic science research but those experiences are probably categorized as secondary/desirable qualifications as most of the employers are looking for a person with IND/NDA/BLA related experience. I completely agree with Lauren about my qualifications which are killing my candidature. It is hard to convince anyone that based on my former experience; I need very little training period to learn IND/NDA/BLA related filing. I will appreciate if you could spare couple of moments to have a look into my resume attached in initial blog.  

Once again my sincere thanks for your suggestions. With regards,

 Nupur

------------------------------------------- Nupur Gangopadhyay Ph.D., RAC Monroeville PA United States -------------------------------------------
Original Message: Sent: 10-25-2014 02:06 From: Albert Wong Subject: How to find a entry level regulatory job Hi Nupur, What I have seen is many of the people around me had jobs in industry prior to transitioning to Regulatory. At my company we have Reg CMC, and Reg Clin/Non-Clin, etc., so for me I was able to utilize my previous experience toward the transition into Regulatory.  Also, I wanted to know if you actually took the certificate courses (certificate) or took the test and became RAC certified. To me they are two different and distinct things. Reading your email, it seems like you took the certificate program, and have not taken the test. I could be wrong, but that is how I read it. Also, I have not seen your resume, but as a hiring manager, I would look at your resume to see what type of regulatory work you did. Even if you were a preclinical scientist, you must have generated reports and IND/NDA/BLA sections of submissions for various compounds. Those would be a good starting point for you. Good luck on your search. And just keep looking. ------------------------------------------- Albert Wong Manager, Regulatory CMC Biomarin Pharmaceutical Inc. San Francisco CA United States -------------------------------------------
Original Message: Sent: 10-21-2014 18:54 From: Nupur Gangopadhyay Subject: How to find a entry level regulatory job Hi members, Recently, I have obtained a RAC certificate (Dual) with an intention of career transition. In spite of numerous application, I have not received single response. I have tried in positions where prior experience not required but no response. It seems, in this profession "no experience-----no job". I will appreciate if you can provide me any advice. I have a background in bio-medical research and reviewer for IRB. Thanks in advance for any form of assistance. Regards, Nupur  ------------------------------------------- Nupur Gangopadhyay D.V.M, M.S.,Ph.D, RAC Monroeville PA United States -------------------------------------------

Hi Steven,

Thanks for your suggestion. I have passed an online course offered by RAPS which is conferred as Regulatory Affair Certificate (RAC). Once again, it is not a certification. Hope things are clear now.

Regards,
Nupur

-------------------------------------------
Nupur Gangopadhyay Ph.D., RAC
Monroeville PA
United States
-------------------------------------------


Original Message:
Sent: 10-26-2014 08:23
From: Steven Lawrie
Subject: How to find a entry level regulatory job

Nupur,

I just wanted to follow up on one thing that I think Albert was bringing to your attention. You list yourself as having the RAC credential, but you description makes it sound like you are doing so after taking the certificate courses. It's a fully understandable confusion, but those courses have nothing to do with the RAC credential. That credential is earned by taking and passing the Regulatory Affairs Certification (RAC) Exam, either for US, EU, Canadian, or Global regulatory affairs. If you are listing yourself on your resume as an RAC and have not passed that exam, that should probably be changed. RAPS maintains a public list of RAC holders, so any company could easily check and see that you aren't one, which would at least give me pause when reviewing an application.

Good luck in your job search!

-------------------------------------------
Steven Lawrie, MS, MA
Regulatory Affairs Team Lead
Cook, Inc.
Bloomington IN
-------------------------------------------

Napur
As others have pointed out, The course you took does not allow you to use the RAC credential.
-------------------------------------------
Joy Frestedt PHD, RAC, FRAPS
President and CEO
Frestedt Incorporated
Saint Louis Park MN
United States
-------------------------------------------



Original Message:
Sent: 10/26/2014 9:16:50 AM
From: nupurnikkan@gmail.com
Subject: RE: How to find a entry level regulatory job

Hi Steven,

Thanks for your suggestion. I have passed an online course offered by RAPS which is conferred as Regulatory Affair Certificate (RAC). Once again, it is not a certification. Hope things are clear now. Regards, Nupur

------------------------------------------- Nupur Gangopadhyay Ph.D., RAC Monroeville PA United States -------------------------------------------
Original Message: Sent: 10-26-2014 08:23 From: Steven Lawrie Subject: How to find a entry level regulatory job Nupur, I just wanted to follow up on one thing that I think Albert was bringing to your attention. You list yourself as having the RAC credential, but you description makes it sound like you are doing so after taking the certificate courses. It's a fully understandable confusion, but those courses have nothing to do with the RAC credential. That credential is earned by taking and passing the Regulatory Affairs Certification (RAC) Exam, either for US, EU, Canadian, or Global regulatory affairs. If you are listing yourself on your resume as an RAC and have not passed that exam, that should probably be changed. RAPS maintains a public list of RAC holders, so any company could easily check and see that you aren't one, which would at least give me pause when reviewing an application. Good luck in your job search! ------------------------------------------- Steven Lawrie, MS, MA Regulatory Affairs Team Lead Cook, Inc. Bloomington IN -------------------------------------------

Napur

Two thoughts about your entry level job seeking post:

1) ensure your resume focuses on your specific regulatory skills and experiences (certifications and courses do not substitute for skills or experiences)

2) rather than simply sending applications to open positions, be sure to network your way to the people who can hire you and use good networking practices to build those relationships!

Keep looking and consider how to get experience. ACRP has a course (and will soon have a publication on the same topic) about how to get an entry level job in clinical research and many of those helpful hints may be helpful to you or others in the same boat (you will need to apply thoughts about regulatory details for the clinical research details in the text). Other published literature may also help you.

Dr Frestedt


-------------------------------------------
Joy Frestedt PHD, RAC, FRAPS
President and CEO
Frestedt Incorporated
Saint Louis Park MN
United States
-------------------------------------------



Original Message:
Sent: 10/25/2014 2:06:02 AM
From: alwong2009@gmail.com
Subject: RE: How to find a entry level regulatory job

Hi Nupur, What I have seen is many of the people around me had jobs in industry prior to transitioning to Regulatory. At my company we have Reg CMC, and Reg Clin/Non-Clin, etc., so for me I was able to utilize my previous experience toward the transition into Regulatory.  Also, I wanted to know if you actually took the certificate courses (certificate) or took the test and became RAC certified. To me they are two different and distinct things. Reading your email, it seems like you took the certificate program, and have not taken the test. I could be wrong, but that is how I read it. Also, I have not seen your resume, but as a hiring manager, I would look at your resume to see what type of regulatory work you did. Even if you were a preclinical scientist, you must have generated reports and IND/NDA/BLA sections of submissions for various compounds. Those would be a good starting point for you. Good luck on your search. And just keep looking. ------------------------------------------- Albert Wong Manager, Regulatory CMC Biomarin Pharmaceutical Inc. San Francisco CA United States -------------------------------------------
Original Message: Sent: 10-21-2014 18:54 From: Nupur Gangopadhyay Subject: How to find a entry level regulatory job Hi members, Recently, I have obtained a RAC certificate (Dual) with an intention of career transition. In spite of numerous application, I have not received single response. I have tried in positions where prior experience not required but no response. It seems, in this profession "no experience-----no job". I will appreciate if you can provide me any advice. I have a background in bio-medical research and reviewer for IRB. Thanks in advance for any form of assistance. Regards, Nupur  ------------------------------------------- Nupur Gangopadhyay D.V.M, M.S.,Ph.D, RAC Monroeville PA United States -------------------------------------------

Hi Joy,

Thanks for your valuable suggestions. Did you mean: the on line course I took does not allow me to write RAC along with other degree which I was awarded in the past? I am trying to verify and does not want to put padding onto my resume. Attached is my certificate to clear the topic/discussion.

Regards,
Nupur 

-------------------------------------------
Nupur Gangopadhyay Ph.D., RAC
Monroeville PA
United States
-------------------------------------------


Original Message:
Sent: 10-26-2014 10:24
From: Joy Frestedt
Subject: How to find a entry level regulatory job

Napur

Two thoughts about your entry level job seeking post:

1) ensure your resume focuses on your specific regulatory skills and experiences (certifications and courses do not substitute for skills or experiences)

2) rather than simply sending applications to open positions, be sure to network your way to the people who can hire you and use good networking practices to build those relationships!

Keep looking and consider how to get experience. ACRP has a course (and will soon have a publication on the same topic) about how to get an entry level job in clinical research and many of those helpful hints may be helpful to you or others in the same boat (you will need to apply thoughts about regulatory details for the clinical research details in the text). Other published literature may also help you.

Dr Frestedt


-------------------------------------------
Joy Frestedt PHD, RAC, FRAPS
President and CEO
Frestedt Incorporated
Saint Louis Park MN
United States
-------------------------------------------

Nupur,

Yes, that was the point Joy and I were making. Referring to yourself as an RAC is unrelated to the certificate courses you took. The RAC Exam is completely separate, and only that allows you to correctly list RAC after your name and on your resume. Personally, I wish they hadn't used the term "certificate" with the courses, since it causes perfectly understandable confusion with the "certification" exams. But yes, unless you've taken and passed one of the four RAC Exams (you can find info about them, and a list of RAC holders on the RAPS website), you would not be able to correctly list "RAC" as you have.

Best,

Steve

-------------------------------------------
Steven Lawrie, MS, MA
Regulatory Affairs Team Lead
Cook, Inc.
Bloomington IN
United States
-------------------------------------------



Original Message:
Sent: 10/26/2014 2:53:34 PM
From: nupurnikkan@gmail.com
Subject: RE: How to find a entry level regulatory job

Hi Joy, Thanks for your valuable suggestions. Did you mean: the on line course I took does not allow me to write RAC along with other degree which I was awarded in the past? I am trying to verify and does not want to put padding onto my resume. Attached is my certificate to clear the topic/discussion. Regards, Nupur  ------------------------------------------- Nupur Gangopadhyay Ph.D., RAC Monroeville PA United States -------------------------------------------
Original Message: Sent: 10-26-2014 10:24 From: Joy Frestedt Subject: How to find a entry level regulatory job Napur Two thoughts about your entry level job seeking post: 1) ensure your resume focuses on your specific regulatory skills and experiences (certifications and courses do not substitute for skills or experiences) 2) rather than simply sending applications to open positions, be sure to network your way to the people who can hire you and use good networking practices to build those relationships! Keep looking and consider how to get experience. ACRP has a course (and will soon have a publication on the same topic) about how to get an entry level job in clinical research and many of those helpful hints may be helpful to you or others in the same boat (you will need to apply thoughts about regulatory details for the clinical research details in the text). Other published literature may also help you. Dr Frestedt ------------------------------------------- Joy Frestedt PHD, RAC, FRAPS President and CEO Frestedt Incorporated Saint Louis Park MN United States -------------------------------------------

Hi Steve.

I completely agree that the term "certificate" in this case is a poor choice especially in light of the RAC credential having absolutely nothing to do with whether or not one completes the certificate courses.

I am wondering, and actually I suspect that it is true, whether the RAPS leadership is monitoring any of this discussion and recognizing what I believe both you and I have found regarding the completely innocent mistake that was made in understanding the difference in the two credentials.

As a hiring manager, if I see someone claim the RAC credential the first place I am going is to the RAPS website where the credential-holding individuals are named.  If that person is not on the listing, then the next thing that is happening for me is the elimination of the candidate for further consideration as it would appear that, knowingly or not, the person has misrepresented himself or herself and their qualifications either on the resume or the cover letter.

I strongly will suggest that RAPS consider this precise problem especially in the view that many people are misled by completing the certificate programs.  A simple fix might be to provide a Pharmaceutical Products Certificate (PPC), a Device Product Certificate (DPC) and a Combination Products Certificate (CPC) which would eliminate the problem and would more accurately show what continuing education the individual has completed without the potential misuse of the RAC credential even unknowingly.

-------------------------------------------
Victor Mencarelli
Sr. Manager - Regulatory Affairs
United States
-------------------------------------------


Original Message:
Sent: 10-27-2014 06:59
From: Steven Lawrie
Subject: How to find a entry level regulatory job

Nupur,

Yes, that was the point Joy and I were making. Referring to yourself as an RAC is unrelated to the certificate courses you took. The RAC Exam is completely separate, and only that allows you to correctly list RAC after your name and on your resume. Personally, I wish they hadn't used the term "certificate" with the courses, since it causes perfectly understandable confusion with the "certification" exams. But yes, unless you've taken and passed one of the four RAC Exams (you can find info about them, and a list of RAC holders on the RAPS website), you would not be able to correctly list "RAC" as you have.

Best,

Steve

-------------------------------------------
Steven Lawrie, MS, MA
Regulatory Affairs Team Lead
Cook, Inc.
Bloomington IN
United States
-------------------------------------------

Victor,

I completely agree with your suggested nomenclature. Hope my candidature to 35 applications were not eliminated because of my unintentional mistake. RAPS should take responsibility for such mistake and fix the problem ASAP.  I am making efforts to communicate with RAPS via open forum as well as email but so far, no response.

Regards,
Nupur
-------------------------------------------
Nupur N. Gangopadhyay, DVM, MS, Ph.D.
Monroeville, PA
USA
-------------------------------------------


Original Message:
Sent: 10-28-2014 08:31
From: Victor Mencarelli
Subject: How to find a entry level regulatory job

Hi Steve.

I completely agree that the term "certificate" in this case is a poor choice especially in light of the RAC credential having absolutely nothing to do with whether or not one completes the certificate courses.

I am wondering, and actually I suspect that it is true, whether the RAPS leadership is monitoring any of this discussion and recognizing what I believe both you and I have found regarding the completely innocent mistake that was made in understanding the difference in the two credentials.

As a hiring manager, if I see someone claim the RAC credential the first place I am going is to the RAPS website where the credential-holding individuals are named.  If that person is not on the listing, then the next thing that is happening for me is the elimination of the candidate for further consideration as it would appear that, knowingly or not, the person has misrepresented himself or herself and their qualifications either on the resume or the cover letter.

I strongly will suggest that RAPS consider this precise problem especially in the view that many people are misled by completing the certificate programs.  A simple fix might be to provide a Pharmaceutical Products Certificate (PPC), a Device Product Certificate (DPC) and a Combination Products Certificate (CPC) which would eliminate the problem and would more accurately show what continuing education the individual has completed without the potential misuse of the RAC credential even unknowingly.

-------------------------------------------
Victor Mencarelli
Sr. Manager - Regulatory Affairs
United States
-------------------------------------------


Original Message:
Sent: 10-27-2014 06:59
From: Steven Lawrie
Subject: How to find a entry level regulatory job

Nupur,

Yes, that was the point Joy and I were making. Referring to yourself as an RAC is unrelated to the certificate courses you took. The RAC Exam is completely separate, and only that allows you to correctly list RAC after your name and on your resume. Personally, I wish they hadn't used the term "certificate" with the courses, since it causes perfectly understandable confusion with the "certification" exams. But yes, unless you've taken and passed one of the four RAC Exams (you can find info about them, and a list of RAC holders on the RAPS website), you would not be able to correctly list "RAC" as you have.

Best,

Steve

-------------------------------------------
Steven Lawrie, MS, MA
Regulatory Affairs Team Lead
Cook, Inc.
Bloomington IN
United States
-------------------------------------------

Hi Napur,

I'm sorry for the confusion about the difference between the RAC credential and RAPS' certificate programs. This question has come up before and we have tried to clarify the difference as follows:

RAC Certification or Certificate Training Program?

The Regulatory Affairs Certification (RAC) is a professional certification. The primary purpose of a professional certification program is to provide an independent assessment of the knowledge, skills and/or competencies required for competent performance of a professional role. This assessment is typically accomplished by the successful completion of an examination.

A certificate training program's primary purpose is to provide education and training so that participants can attain defined learning objectives. Although assessment is a part of a certificate training program, the assessment is conducted to evaluate the attainment of the learning objectives. 

We have included this clarification on key pages of the RAPS website and in other communications about the RAC credential or the certificate programs, but obviously there is still potential for confusion.

We appreciate everyone's input on this; I will pass these comments along to my colleagues here at RAPS for further consideration.
 
-------------------------------------------
Zachary Brousseau
Senior Manager, Communications
RAPS
Rockville, MD, United States
-------------------------------------------


Original Message:
Sent: 10-28-2014 09:56
From: Nupur Gangopadhyay
Subject: How to find a entry level regulatory job


Victor,

I completely agree with your suggested nomenclature. Hope my candidature to 35 applications were not eliminated because of my unintentional mistake. RAPS should take responsibility for such mistake and fix the problem ASAP.  I am making efforts to communicate with RAPS via open forum as well as email but so far, no response.

Regards,
Nupur
-------------------------------------------
Nupur N. Gangopadhyay, DVM, MS, Ph.D.
Monroeville, PA
USA
-------------------------------------------


Original Message:
Sent: 10-28-2014 08:31
From: Victor Mencarelli
Subject: How to find a entry level regulatory job

Hi Steve.

I completely agree that the term "certificate" in this case is a poor choice especially in light of the RAC credential having absolutely nothing to do with whether or not one completes the certificate courses.

I am wondering, and actually I suspect that it is true, whether the RAPS leadership is monitoring any of this discussion and recognizing what I believe both you and I have found regarding the completely innocent mistake that was made in understanding the difference in the two credentials.

As a hiring manager, if I see someone claim the RAC credential the first place I am going is to the RAPS website where the credential-holding individuals are named.  If that person is not on the listing, then the next thing that is happening for me is the elimination of the candidate for further consideration as it would appear that, knowingly or not, the person has misrepresented himself or herself and their qualifications either on the resume or the cover letter.

I strongly will suggest that RAPS consider this precise problem especially in the view that many people are misled by completing the certificate programs.  A simple fix might be to provide a Pharmaceutical Products Certificate (PPC), a Device Product Certificate (DPC) and a Combination Products Certificate (CPC) which would eliminate the problem and would more accurately show what continuing education the individual has completed without the potential misuse of the RAC credential even unknowingly.

-------------------------------------------
Victor Mencarelli
Sr. Manager - Regulatory Affairs
United States
-------------------------------------------


Original Message:
Sent: 10-27-2014 06:59
From: Steven Lawrie
Subject: How to find a entry level regulatory job

Nupur,

Yes, that was the point Joy and I were making. Referring to yourself as an RAC is unrelated to the certificate courses you took. The RAC Exam is completely separate, and only that allows you to correctly list RAC after your name and on your resume. Personally, I wish they hadn't used the term "certificate" with the courses, since it causes perfectly understandable confusion with the "certification" exams. But yes, unless you've taken and passed one of the four RAC Exams (you can find info about them, and a list of RAC holders on the RAPS website), you would not be able to correctly list "RAC" as you have.

Best,

Steve

-------------------------------------------
Steven Lawrie, MS, MA
Regulatory Affairs Team Lead
Cook, Inc.
Bloomington IN
United States
-------------------------------------------

My response to Zachary's explanation

Hi Zachary,

Thanks for your response but, unfortunately, your response does not answer my question. Have you got a chance to read my mail? Let me try again:

"Recently, I have completed an online course on Regulatory Affairs Certificate (Dual) and accordingly obtained a certificate. As most of the degree abbreviation method, I was using this certificate as RAC after my other degrees but most of the RAPS members pointed out that RAC is stand for certification. In this context, more elaborately, examples are: Bachelor of Science= B.S., Master of Science= M.S., Membership of the Royal College of Surgeons (M.R.C.S), Fellow of the American College of Surgeons = FACS, Certified public accountant (CPA), etc. What should be correct and accepted abbreviation for a certificate on Regulatory Affairs Certificate (Dual)? Should be RAC? Or does not have any abbreviation".

Additionally, do you recognize that in the RAPS web site, the course I have taken is being encouraged in comparison to certification that is less costly. Also, dual course is not for a career transition. How many people got an entry level job after taking this course? We talk so much about mislabeling/misbranding throughout the course, but it seems RAPS is not maintaining the ethics while selling products (courses) specifically, to those naïve customers like me. Had I knew, certification has more value; I would have taken that course. Most probably, all my candidature in applications has been null and void because I wrote RAC next to my other abbreviated qualification. Do you think your organization can take any form of responsibility for the above act? Right now, I am an unemployed person and wasting a single penny hurts.   

Thanks for your efforts in explaining me again.

With regards,

Nupur

 

-------------------------------------------
Nupur N. Gangopadhyay, DVM, MS, Ph.D.
Monroeville, PA
USA
-------------------------------------------


Original Message:
Sent: 10-28-2014 09:56
From: Nupur Gangopadhyay
Subject: How to find a entry level regulatory job


Victor,

I completely agree with your suggested nomenclature. Hope my candidature to 35 applications were not eliminated because of my unintentional mistake. RAPS should take responsibility for such mistake and fix the problem ASAP.  I am making efforts to communicate with RAPS via open forum as well as email but so far, no response.

Regards,
Nupur
-------------------------------------------
Nupur N. Gangopadhyay, DVM, MS, Ph.D.
Monroeville, PA
USA
-------------------------------------------


Original Message:
Sent: 10-28-2014 08:31
From: Victor Mencarelli
Subject: How to find a entry level regulatory job

Hi Steve.

I completely agree that the term "certificate" in this case is a poor choice especially in light of the RAC credential having absolutely nothing to do with whether or not one completes the certificate courses.

I am wondering, and actually I suspect that it is true, whether the RAPS leadership is monitoring any of this discussion and recognizing what I believe both you and I have found regarding the completely innocent mistake that was made in understanding the difference in the two credentials.

As a hiring manager, if I see someone claim the RAC credential the first place I am going is to the RAPS website where the credential-holding individuals are named.  If that person is not on the listing, then the next thing that is happening for me is the elimination of the candidate for further consideration as it would appear that, knowingly or not, the person has misrepresented himself or herself and their qualifications either on the resume or the cover letter.

I strongly will suggest that RAPS consider this precise problem especially in the view that many people are misled by completing the certificate programs.  A simple fix might be to provide a Pharmaceutical Products Certificate (PPC), a Device Product Certificate (DPC) and a Combination Products Certificate (CPC) which would eliminate the problem and would more accurately show what continuing education the individual has completed without the potential misuse of the RAC credential even unknowingly.

-------------------------------------------
Victor Mencarelli
Sr. Manager - Regulatory Affairs
United States
-------------------------------------------


Original Message:
Sent: 10-27-2014 06:59
From: Steven Lawrie
Subject: How to find a entry level regulatory job

Nupur,

Yes, that was the point Joy and I were making. Referring to yourself as an RAC is unrelated to the certificate courses you took. The RAC Exam is completely separate, and only that allows you to correctly list RAC after your name and on your resume. Personally, I wish they hadn't used the term "certificate" with the courses, since it causes perfectly understandable confusion with the "certification" exams. But yes, unless you've taken and passed one of the four RAC Exams (you can find info about them, and a list of RAC holders on the RAPS website), you would not be able to correctly list "RAC" as you have.

Best,

Steve

-------------------------------------------
Steven Lawrie, MS, MA
Regulatory Affairs Team Lead
Cook, Inc.
Bloomington IN
United States
-------------------------------------------

I would like to second Victor's suggestion and ask that RAPS consider altering the acronyms for the certificate programs.

Indeed, RAPS has made the distinction clear on its website. But how much easier would it be if the acronyms themselves were different to begin with?

I find that in a field where the rampant use of acronyms requires a high degree of concentration owing to the fact that very different terms have the same first letter ("D" can be device or drug, "P" can be product, pharmaceuitical, patient or physician), it can be too easy to mix up terms. DHF, DHR, DMF, DMR, PDP, PI, PPI......

Since RAPS offers both the certification and the certificate, why not adopt an acronym system that leaves our brains free to keep track of all the other similar acronyms that are out there?

If FDA can reclassify devices into new procodes, RAPS is surely entitled to "reclassify" certificates.

-------------------------------------------
Jean Bigoney PHD
Managing Member
Nu Device Consulting LLC
Newport NH
United States
-------------------------------------------


Original Message:
Sent: 10-28-2014 08:31
From: Victor Mencarelli
Subject: How to find a entry level regulatory job

Hi Steve.

...
I strongly will suggest that RAPS consider this precise problem especially in the view that many people are misled by completing the certificate programs.  A simple fix might be to provide a Pharmaceutical Products Certificate (PPC), a Device Product Certificate (DPC) and a Combination Products Certificate (CPC) which would eliminate the problem and would more accurately show what continuing education the individual has completed without the potential misuse of the RAC credential even unknowingly.

-------------------------------------------
Victor Mencarelli
Sr. Manager - Regulatory Affairs
United States
-------------------------------------------

As for "how much easier would it be if the acronyms themselves were different to begin with?", I agree with the following clarification.

RAPS doesn't use "acronyms" for the following certificates.  It seems someone created/used the acronym to refer to the third certificate on his own initiatives.

In fact, when one describes his/her certificate for any of the following in his/her resume/CV, it has been my understanding that one should exactly state ["Regulatory Affairs Certificate - Medical Devices" from RAPS].

Question: Does RAPS have to deal with acronyms created by others on his/her initiatives leading to confusion when it was made clear as follows and also as pointed out by Jean?

Regulatory Affairs Certificate: Medical Devices
Regulatory Affairs Certificate: Pharmaceuticals
Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals (Dual)

As for the term "Pharmaceutical Products Certificate," RAPS online program covers regulations and regulatory aspects applicable to pharmaceuticals (not specifically covering product aspects per se).  If RAPS ever decides to name each certificate, it should consider actually capturing the contents of online class as follows and should also consider offering different levels.

Regulatory Certificate I in Drugs (RCD I), referring to level 1
Regulatory Certificate II in Drugs (RCD II), referring to level 2
RCD III
RCD IV

Regulatory Certificate I in Medical Devices (RCMD I)
Regulatory Certificate II in Medical Devices (RCMD II)
RCMD III
RCMD IV

etc. 

Just my thoughts!

FYI:  I offer few online programs different from RAPS as I mainly cover regulatory drafting/writing aspects.  


Original Message:
Sent: 10-29-2014 08:50
From: Jean Bigoney
Subject: How to find a entry level regulatory job

I would like to second Victor's suggestion and ask that RAPS consider altering the acronyms for the certificate programs.

Indeed, RAPS has made the distinction clear on its website. But how much easier would it be if the acronyms themselves were different to begin with?

I find that in a field where the rampant use of acronyms requires a high degree of concentration owing to the fact that very different terms have the same first letter ("D" can be device or drug, "P" can be product, pharmaceuitical, patient or physician), it can be too easy to mix up terms. DHF, DHR, DMF, DMR, PDP, PI, PPI......

Since RAPS offers both the certification and the certificate, why not adopt an acronym system that leaves our brains free to keep track of all the other similar acronyms that are out there?

If FDA can reclassify devices into new procodes, RAPS is surely entitled to "reclassify" certificates.

-------------------------------------------
Jean Bigoney PHD
Managing Member
Nu Device Consulting LLC
Newport NH
United States
-------------------------------------------


Original Message:
Sent: 10-28-2014 08:31
From: Victor Mencarelli
Subject: How to find a entry level regulatory job

Hi Steve.

...
I strongly will suggest that RAPS consider this precise problem especially in the view that many people are misled by completing the certificate programs.  A simple fix might be to provide a Pharmaceutical Products Certificate (PPC), a Device Product Certificate (DPC) and a Combination Products Certificate (CPC) which would eliminate the problem and would more accurately show what continuing education the individual has completed without the potential misuse of the RAC credential even unknowingly.

-------------------------------------------
Victor Mencarelli
Sr. Manager - Regulatory Affairs
United States
-------------------------------------------

Thanks for you explanation. I wish RAPS can realize the problem. Also, they should be more transparent and fair in advertisement policy for any courses. Using online dictionary, it is easy to define a difference between certificate-vs certification. We got enough education on definition! I wish,  I knew about your course before wasting my money onto a confusing and unrecognized course material. 
-------------------------------------------
Nupur N. Gangopadhyay, DVM, MS, Ph.D.
Monroeville, PA
USA
-------------------------------------------


Original Message:
Sent: 10-29-2014 09:42
From: David Lim
Subject: How to find a entry level regulatory job

As for "how much easier would it be if the acronyms themselves were different to begin with?", I agree with the following clarification.

RAPS doesn't use "acronyms" for the following certificates.  It seems someone created/used the acronym to refer to the third certificate on his own initiatives.

In fact, when one describes his/her certificate for any of the following in his/her resume/CV, it has been my understanding that one should exactly state ["Regulatory Affairs Certificate - Medical Devices" from RAPS].

Question: Does RAPS have to deal with acronyms created by others on his/her initiatives leading to confusion when it was made clear as follows and also as pointed out by Jean?

Regulatory Affairs Certificate: Medical Devices
Regulatory Affairs Certificate: Pharmaceuticals
Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals (Dual)

As for the term "Pharmaceutical Products Certificate," RAPS online program covers regulations and regulatory aspects applicable to pharmaceuticals (not specifically covering product aspects per se).  If RAPS ever decides to name each certificate, it should consider actually capturing the contents of online class as follows and should also consider offering different levels.

Regulatory Certificate I in Drugs (RCD I), referring to level 1
Regulatory Certificate II in Drugs (RCD II), referring to level 2
RCD III
RCD IV

Regulatory Certificate I in Medical Devices (RCMD I)
Regulatory Certificate II in Medical Devices (RCMD II)
RCMD III
RCMD IV

etc. 

Just my thoughts!

FYI:  I offer few online programs different from RAPS as I mainly cover regulatory drafting/writing aspects.  


Original Message:
Sent: 10-29-2014 08:50
From: Jean Bigoney
Subject: How to find a entry level regulatory job

I would like to second Victor's suggestion and ask that RAPS consider altering the acronyms for the certificate programs.

Indeed, RAPS has made the distinction clear on its website. But how much easier would it be if the acronyms themselves were different to begin with?

I find that in a field where the rampant use of acronyms requires a high degree of concentration owing to the fact that very different terms have the same first letter ("D" can be device or drug, "P" can be product, pharmaceuitical, patient or physician), it can be too easy to mix up terms. DHF, DHR, DMF, DMR, PDP, PI, PPI......

Since RAPS offers both the certification and the certificate, why not adopt an acronym system that leaves our brains free to keep track of all the other similar acronyms that are out there?

If FDA can reclassify devices into new procodes, RAPS is surely entitled to "reclassify" certificates.

-------------------------------------------
Jean Bigoney PHD
Managing Member
Nu Device Consulting LLC
Newport NH
United States
-------------------------------------------


Original Message:
Sent: 10-28-2014 08:31
From: Victor Mencarelli
Subject: How to find a entry level regulatory job

Hi Steve.

...
I strongly will suggest that RAPS consider this precise problem especially in the view that many people are misled by completing the certificate programs.  A simple fix might be to provide a Pharmaceutical Products Certificate (PPC), a Device Product Certificate (DPC) and a Combination Products Certificate (CPC) which would eliminate the problem and would more accurately show what continuing education the individual has completed without the potential misuse of the RAC credential even unknowingly.

-------------------------------------------
Victor Mencarelli
Sr. Manager - Regulatory Affairs
United States
-------------------------------------------

Nupur,

Thank you for continuing conversation/discussion.

What you have learned though will be very helpful for broadening your view and navigating your options including when/if you decide to sit for the RAC later.

If you want to get engaged in discussion in a fun way, please join RAC at FACEBOOK (https://www.facebook.com/groups/StudyRAC/)

Wishing you all the very best!



Original Message:
Sent: 10-29-2014 10:33
From: Nupur Gangopadhyay
Subject: How to find a entry level regulatory job




Thanks for you explanation. I wish RAPS can realize the problem. Also, they should be more transparent and fair in advertisement policy for any courses. Using online dictionary, it is easy to define a difference between certificate-vs certification. We got enough education on definition! I wish,  I knew about your course before wasting my money onto a confusing and unrecognized course material. 
-------------------------------------------
Nupur N. Gangopadhyay, DVM, MS, Ph.D.
Monroeville, PA
USA
-------------------------------------------


Original Message:
Sent: 10-29-2014 09:42
From: David Lim
Subject: How to find a entry level regulatory job

As for "how much easier would it be if the acronyms themselves were different to begin with?", I agree with the following clarification.

RAPS doesn't use "acronyms" for the following certificates.  It seems someone created/used the acronym to refer to the third certificate on his own initiatives.

In fact, when one describes his/her certificate for any of the following in his/her resume/CV, it has been my understanding that one should exactly state ["Regulatory Affairs Certificate - Medical Devices" from RAPS].

Question: Does RAPS have to deal with acronyms created by others on his/her initiatives leading to confusion when it was made clear as follows and also as pointed out by Jean?

Regulatory Affairs Certificate: Medical Devices
Regulatory Affairs Certificate: Pharmaceuticals
Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals (Dual)

As for the term "Pharmaceutical Products Certificate," RAPS online program covers regulations and regulatory aspects applicable to pharmaceuticals (not specifically covering product aspects per se).  If RAPS ever decides to name each certificate, it should consider actually capturing the contents of online class as follows and should also consider offering different levels.

Regulatory Certificate I in Drugs (RCD I), referring to level 1
Regulatory Certificate II in Drugs (RCD II), referring to level 2
RCD III
RCD IV

Regulatory Certificate I in Medical Devices (RCMD I)
Regulatory Certificate II in Medical Devices (RCMD II)
RCMD III
RCMD IV

etc. 

Just my thoughts!

FYI:  I offer few online programs different from RAPS as I mainly cover regulatory drafting/writing aspects.  


Original Message:
Sent: 10-29-2014 08:50
From: Jean Bigoney
Subject: How to find a entry level regulatory job

I would like to second Victor's suggestion and ask that RAPS consider altering the acronyms for the certificate programs.

Indeed, RAPS has made the distinction clear on its website. But how much easier would it be if the acronyms themselves were different to begin with?

I find that in a field where the rampant use of acronyms requires a high degree of concentration owing to the fact that very different terms have the same first letter ("D" can be device or drug, "P" can be product, pharmaceuitical, patient or physician), it can be too easy to mix up terms. DHF, DHR, DMF, DMR, PDP, PI, PPI......

Since RAPS offers both the certification and the certificate, why not adopt an acronym system that leaves our brains free to keep track of all the other similar acronyms that are out there?

If FDA can reclassify devices into new procodes, RAPS is surely entitled to "reclassify" certificates.

-------------------------------------------
Jean Bigoney PHD
Managing Member
Nu Device Consulting LLC
Newport NH
United States
-------------------------------------------


Original Message:
Sent: 10-28-2014 08:31
From: Victor Mencarelli
Subject: How to find a entry level regulatory job

Hi Steve.

...
I strongly will suggest that RAPS consider this precise problem especially in the view that many people are misled by completing the certificate programs.  A simple fix might be to provide a Pharmaceutical Products Certificate (PPC), a Device Product Certificate (DPC) and a Combination Products Certificate (CPC) which would eliminate the problem and would more accurately show what continuing education the individual has completed without the potential misuse of the RAC credential even unknowingly.

-------------------------------------------
Victor Mencarelli
Sr. Manager - Regulatory Affairs
United States
-------------------------------------------

Nupur,

I have quickly looked at your resume. Based on my 30 second review, I probably would have to pass also. It seems like you have a TON of experience, but nothing on your resume screams that you have done anything related to regulatory. I was in your same position a year ago, but as you look back in your career, everything you have done have some component of regulatory involved. you will need to modify your resume to focus on those skills that could translate into a regulatory position.

One suggestions is for you to contact a temp agency that focuses on regulatory positions. The recruiter may have open positions for someone with your experiences. The recruiter may also be able to help you re-write your resume.

There are many people who have a ton of experience that want to transition into reg, it is all about presentation. That is how you will get your foot in the door. Good luck.

Albert

-------------------------------------------
Albert Wong
Manager, Regulatory CMC
Biomarin Pharmaceutical Inc.
San Francisco CA
United States
-------------------------------------------


Original Message:
Sent: 10-21-2014 18:54
From: Nupur Gangopadhyay
Subject: How to find a entry level regulatory job

Hi members,

Recently, I have obtained a RAC certificate (Dual) with an intention of career transition. In spite of numerous application, I have not received single response. I have tried in positions where prior experience not required but no response. It seems, in this profession "no experience-----no job". I will appreciate if you can provide me any advice. I have a background in bio-medical research and reviewer for IRB. Thanks in advance for any form of assistance.

Regards,
Nupur 


-------------------------------------------
Nupur Gangopadhyay D.V.M, M.S.,Ph.D, RAC
Monroeville PA
United States
-------------------------------------------

Thanks lot Albert, Nupur

-------------------------------------------
Nupur Gangopadhyay Ph.D., RAC
Monroeville PA
United States
-------------------------------------------


Original Message:
Sent: 10-26-2014 11:13
From: Albert Wong
Subject: How to find a entry level regulatory job

Nupur,

I have quickly looked at your resume. Based on my 30 second review, I probably would have to pass also. It seems like you have a TON of experience, but nothing on your resume screams that you have done anything related to regulatory. I was in your same position a year ago, but as you look back in your career, everything you have done have some component of regulatory involved. you will need to modify your resume to focus on those skills that could translate into a regulatory position.

One suggestions is for you to contact a temp agency that focuses on regulatory positions. The recruiter may have open positions for someone with your experiences. The recruiter may also be able to help you re-write your resume.

There are many people who have a ton of experience that want to transition into reg, it is all about presentation. That is how you will get your foot in the door. Good luck.

Albert

-------------------------------------------
Albert Wong
Manager, Regulatory CMC
Biomarin Pharmaceutical Inc.
San Francisco CA
United States
-------------------------------------------


Original Message:
Sent: 10-21-2014 18:54
From: Nupur Gangopadhyay
Subject: How to find a entry level regulatory job

Hi members,

Recently, I have obtained a RAC certificate (Dual) with an intention of career transition. In spite of numerous application, I have not received single response. I have tried in positions where prior experience not required but no response. It seems, in this profession "no experience-----no job". I will appreciate if you can provide me any advice. I have a background in bio-medical research and reviewer for IRB. Thanks in advance for any form of assistance.

Regards,
Nupur 


-------------------------------------------
Nupur Gangopadhyay D.V.M, M.S.,Ph.D, RAC
Monroeville PA
United States
-------------------------------------------

All,

I think that the proposal to change the acronym(s) for the certificate programs is well intentioned, but could create more issues than it solves.  There are certificates and certifications in a wide variety of fields, and the terms nearly always refer to two distinctly different things.  A certificate means that you have completed a continuing education program designed to provide some level of exposure to a body of knowledge.  These vary widely in quality and depth depending on who offers it.  Conversely, a certification is a standardized designation conferred by a professional body meant to show that the individual has attained a deeper level of understanding of that body of knowledge through study and experience.  That's why you need a certain amount of experience and/or postgraduate education in order to qualify to sit for a certification exam.  It's also why a well-designed certification exam presents questions from various levels of Bloom's taxonomy, is written with heavy involvement from the member body, and is scored in a highly standardized manner.  By convention, recognized certifications may appear along with degrees in one's professional name.  A certificate program could appear in the body of a resume under "addtional training," but not with a name and degree.  So, changing the abbreviation for the RA certificate programs (which really don't have an abbreviation at all that's listed by RAPS, at least that I can find), has the potential to dilute the value of the RAC if those abbreviations can be listed in the same way as the RAC.

-------------------------------------------
Craig A Claussen PhD, RAC
Schaumburg IL
United States
-------------------------------------------


Original Message:
Sent: 10-26-2014 14:41
From: Nupur Gangopadhyay
Subject: How to find a entry level regulatory job

Thanks lot Albert, Nupur

-------------------------------------------
Nupur Gangopadhyay Ph.D., RAC
Monroeville PA
United States
-------------------------------------------


Original Message:
Sent: 10-26-2014 11:13
From: Albert Wong
Subject: How to find a entry level regulatory job

Nupur,

I have quickly looked at your resume. Based on my 30 second review, I probably would have to pass also. It seems like you have a TON of experience, but nothing on your resume screams that you have done anything related to regulatory. I was in your same position a year ago, but as you look back in your career, everything you have done have some component of regulatory involved. you will need to modify your resume to focus on those skills that could translate into a regulatory position.

One suggestions is for you to contact a temp agency that focuses on regulatory positions. The recruiter may have open positions for someone with your experiences. The recruiter may also be able to help you re-write your resume.

There are many people who have a ton of experience that want to transition into reg, it is all about presentation. That is how you will get your foot in the door. Good luck.

Albert

-------------------------------------------
Albert Wong
Manager, Regulatory CMC
Biomarin Pharmaceutical Inc.
San Francisco CA
United States
-------------------------------------------


Original Message:
Sent: 10-21-2014 18:54
From: Nupur Gangopadhyay
Subject: How to find a entry level regulatory job

Hi members,

Recently, I have obtained a RAC certificate (Dual) with an intention of career transition. In spite of numerous application, I have not received single response. I have tried in positions where prior experience not required but no response. It seems, in this profession "no experience-----no job". I will appreciate if you can provide me any advice. I have a background in bio-medical research and reviewer for IRB. Thanks in advance for any form of assistance.

Regards,
Nupur 


-------------------------------------------
Nupur Gangopadhyay D.V.M, M.S.,Ph.D, RAC
Monroeville PA
United States
-------------------------------------------

Hi Craig,

I appreciate your explanation and definition. Unfortunately, attached document is not written as it should appear. In the past, I took several continuing education program and accordingly completion document appears completely different than the attached one. I have no problem to understand the difference between certificate and certification. I would like to see RAPS's transparency and fairness. Based on my background, probably I could have taken a certification examination.

Regards,
Nupur

-------------------------------------------
Nupur N. Gangopadhyay, DVM, MS, Ph.D.
Monroeville, PA
USA
-------------------------------------------


Original Message:
Sent: 10-29-2014 09:17
From: Craig Claussen
Subject: How to find a entry level regulatory job

All,

I think that the proposal to change the acronym(s) for the certificate programs is well intentioned, but could create more issues than it solves.  There are certificates and certifications in a wide variety of fields, and the terms nearly always refer to two distinctly different things.  A certificate means that you have completed a continuing education program designed to provide some level of exposure to a body of knowledge.  These vary widely in quality and depth depending on who offers it.  Conversely, a certification is a standardized designation conferred by a professional body meant to show that the individual has attained a deeper level of understanding of that body of knowledge through study and experience.  That's why you need a certain amount of experience and/or postgraduate education in order to qualify to sit for a certification exam.  It's also why a well-designed certification exam presents questions from various levels of Bloom's taxonomy, is written with heavy involvement from the member body, and is scored in a highly standardized manner.  By convention, recognized certifications may appear along with degrees in one's professional name.  A certificate program could appear in the body of a resume under "addtional training," but not with a name and degree.  So, changing the abbreviation for the RA certificate programs (which really don't have an abbreviation at all that's listed by RAPS, at least that I can find), has the potential to dilute the value of the RAC if those abbreviations can be listed in the same way as the RAC.

-------------------------------------------
Craig A Claussen PhD, RAC
Schaumburg IL
United States
-------------------------------------------


Original Message:
Sent: 10-26-2014 14:41
From: Nupur Gangopadhyay
Subject: How to find a entry level regulatory job

Thanks lot Albert, Nupur

-------------------------------------------
Nupur Gangopadhyay Ph.D., RAC
Monroeville PA
United States
-------------------------------------------


Original Message:
Sent: 10-26-2014 11:13
From: Albert Wong
Subject: How to find a entry level regulatory job

Nupur,

I have quickly looked at your resume. Based on my 30 second review, I probably would have to pass also. It seems like you have a TON of experience, but nothing on your resume screams that you have done anything related to regulatory. I was in your same position a year ago, but as you look back in your career, everything you have done have some component of regulatory involved. you will need to modify your resume to focus on those skills that could translate into a regulatory position.

One suggestions is for you to contact a temp agency that focuses on regulatory positions. The recruiter may have open positions for someone with your experiences. The recruiter may also be able to help you re-write your resume.

There are many people who have a ton of experience that want to transition into reg, it is all about presentation. That is how you will get your foot in the door. Good luck.

Albert

-------------------------------------------
Albert Wong
Manager, Regulatory CMC
Biomarin Pharmaceutical Inc.
San Francisco CA
United States
-------------------------------------------


Original Message:
Sent: 10-21-2014 18:54
From: Nupur Gangopadhyay
Subject: How to find a entry level regulatory job

Hi members,

Recently, I have obtained a RAC certificate (Dual) with an intention of career transition. In spite of numerous application, I have not received single response. I have tried in positions where prior experience not required but no response. It seems, in this profession "no experience-----no job". I will appreciate if you can provide me any advice. I have a background in bio-medical research and reviewer for IRB. Thanks in advance for any form of assistance.

Regards,
Nupur 


-------------------------------------------
Nupur Gangopadhyay D.V.M, M.S.,Ph.D, RAC
Monroeville PA
United States
-------------------------------------------

Sorry, Napur, if I misunderstood your question.  I will do my best to address it now.

 

You asked what the acronym is for RAPS' Regulatory Affairs Certificate Program. As David Lim pointed out in a subsequent response, RAPS does not use acronyms to indicate completion of the certificate programs as completion does not result in a professional credential. As Craig Claussen wrote in another response, it would be appropriate to list the certificate on a candidate's resume under additional training-no acronym needed.

 

I hope you will find the certificate you completed to be valuable to both your knowledge of regulatory affairs and to your job search as an indication of your commitment to transitioning into a regulatory position.  We feel strongly that RAPS' online training courses are the best in their class, and we have received a lot of positive feedback in support.

 

As has been discussed here, the linguistic similarity between "certificate" and "certification" carries with it the risk of some confusion. RAPS has tried very hard to clarify the difference in all relevant communications. You indicated that you feel RAPS has not adequately accomplished this, and I would like to hear your input on how our communications can be clearer on this point. Please contact me directly at zbrousseau@raps.org. If anyone else would like to provide additional input, I welcome that as well.

Best,
Zac
-------------------------------------------
Zachary Brousseau
Senior Manager, Communications
RAPS
Rockville, MD, United States
-------------------------------------------


Original Message:
Sent: 10-29-2014 09:55
From: Nupur Gangopadhyay
Subject: How to find a entry level regulatory job

Hi Craig,

I appreciate your explanation and definition. Unfortunately, attached document is not written as it should appear. In the past, I took several continuing education program and accordingly completion document appears completely different than the attached one. I have no problem to understand the difference between certificate and certification. I would like to see RAPS's transparency and fairness. Based on my background, probably I could have taken a certification examination.

Regards,
Nupur

-------------------------------------------
Nupur N. Gangopadhyay, DVM, MS, Ph.D.
Monroeville, PA
USA
-------------------------------------------


Original Message:
Sent: 10-29-2014 09:17
From: Craig Claussen
Subject: How to find a entry level regulatory job

All,

I think that the proposal to change the acronym(s) for the certificate programs is well intentioned, but could create more issues than it solves.  There are certificates and certifications in a wide variety of fields, and the terms nearly always refer to two distinctly different things.  A certificate means that you have completed a continuing education program designed to provide some level of exposure to a body of knowledge.  These vary widely in quality and depth depending on who offers it.  Conversely, a certification is a standardized designation conferred by a professional body meant to show that the individual has attained a deeper level of understanding of that body of knowledge through study and experience.  That's why you need a certain amount of experience and/or postgraduate education in order to qualify to sit for a certification exam.  It's also why a well-designed certification exam presents questions from various levels of Bloom's taxonomy, is written with heavy involvement from the member body, and is scored in a highly standardized manner.  By convention, recognized certifications may appear along with degrees in one's professional name.  A certificate program could appear in the body of a resume under "addtional training," but not with a name and degree.  So, changing the abbreviation for the RA certificate programs (which really don't have an abbreviation at all that's listed by RAPS, at least that I can find), has the potential to dilute the value of the RAC if those abbreviations can be listed in the same way as the RAC.

-------------------------------------------
Craig A Claussen PhD, RAC
Schaumburg IL
United States
-------------------------------------------


Original Message:
Sent: 10-26-2014 14:41
From: Nupur Gangopadhyay
Subject: How to find a entry level regulatory job

Thanks lot Albert, Nupur

-------------------------------------------
Nupur Gangopadhyay Ph.D., RAC
Monroeville PA
United States
-------------------------------------------


Original Message:
Sent: 10-26-2014 11:13
From: Albert Wong
Subject: How to find a entry level regulatory job

Nupur,

I have quickly looked at your resume. Based on my 30 second review, I probably would have to pass also. It seems like you have a TON of experience, but nothing on your resume screams that you have done anything related to regulatory. I was in your same position a year ago, but as you look back in your career, everything you have done have some component of regulatory involved. you will need to modify your resume to focus on those skills that could translate into a regulatory position.

One suggestions is for you to contact a temp agency that focuses on regulatory positions. The recruiter may have open positions for someone with your experiences. The recruiter may also be able to help you re-write your resume.

There are many people who have a ton of experience that want to transition into reg, it is all about presentation. That is how you will get your foot in the door. Good luck.

Albert

-------------------------------------------
Albert Wong
Manager, Regulatory CMC
Biomarin Pharmaceutical Inc.
San Francisco CA
United States
-------------------------------------------


Original Message:
Sent: 10-21-2014 18:54
From: Nupur Gangopadhyay
Subject: How to find a entry level regulatory job

Hi members,

Recently, I have obtained a RAC certificate (Dual) with an intention of career transition. In spite of numerous application, I have not received single response. I have tried in positions where prior experience not required but no response. It seems, in this profession "no experience-----no job". I will appreciate if you can provide me any advice. I have a background in bio-medical research and reviewer for IRB. Thanks in advance for any form of assistance.

Regards,
Nupur 


-------------------------------------------
Nupur Gangopadhyay D.V.M, M.S.,Ph.D, RAC
Monroeville PA
United States
-------------------------------------------

Hi Zac,

Thanks for response. In order to make this conversation nice and crispy, you are welcome to answer next to my quarry.

1. As other members suggested does RAPS can change the nomenclature of the certificate?

2. What does attached piece of document stands for?

3. Why in the attached document and in the course advertisement, things are not written clearly? Of-course, I am talking about " this course is an online training which has no curriculum value" or " this is a continuing education program and does not confer a certificate" or any forms of of statement which will clearly explain that no certificate will be provided.

4. In the legal of view or ethical point of view does your explanation matches with attached document?

Honestly, I do not see (neither as water mark or as small letters with statuary warning) any hints of your explanation in the document issues to me. Hope I have convinced you enough regarding this issue.

Friend, nothing personal. All I am trying to do here to fix an inherent problem. 

With my best regards,

Nupur

-------------------------------------------
Nupur N. Gangopadhyay, DVM, MS, Ph.D.
Monroeville, PA
USA
-------------------------------------------


Original Message:
Sent: 10-29-2014 13:14
From: Zachary Brousseau
Subject: How to find a entry level regulatory job

Sorry, Napur, if I misunderstood your question.  I will do my best to address it now.

 

You asked what the acronym is for RAPS' Regulatory Affairs Certificate Program. As David Lim pointed out in a subsequent response, RAPS does not use acronyms to indicate completion of the certificate programs as completion does not result in a professional credential. As Craig Claussen wrote in another response, it would be appropriate to list the certificate on a candidate's resume under additional training-no acronym needed.

 

I hope you will find the certificate you completed to be valuable to both your knowledge of regulatory affairs and to your job search as an indication of your commitment to transitioning into a regulatory position.  We feel strongly that RAPS' online training courses are the best in their class, and we have received a lot of positive feedback in support.

 

As has been discussed here, the linguistic similarity between "certificate" and "certification" carries with it the risk of some confusion. RAPS has tried very hard to clarify the difference in all relevant communications. You indicated that you feel RAPS has not adequately accomplished this, and I would like to hear your input on how our communications can be clearer on this point. Please contact me directly at zbrousseau@raps.org. If anyone else would like to provide additional input, I welcome that as well.

Best,
Zac
-------------------------------------------
Zachary Brousseau
Senior Manager, Communications
RAPS
Rockville, MD, United States
-------------------------------------------


Original Message:
Sent: 10-29-2014 09:55
From: Nupur Gangopadhyay
Subject: How to find a entry level regulatory job

Hi Craig,

I appreciate your explanation and definition. Unfortunately, attached document is not written as it should appear. In the past, I took several continuing education program and accordingly completion document appears completely different than the attached one. I have no problem to understand the difference between certificate and certification. I would like to see RAPS's transparency and fairness. Based on my background, probably I could have taken a certification examination.

Regards,
Nupur

-------------------------------------------
Nupur N. Gangopadhyay, DVM, MS, Ph.D.
Monroeville, PA
USA
-------------------------------------------


Original Message:
Sent: 10-29-2014 09:17
From: Craig Claussen
Subject: How to find a entry level regulatory job

All,

I think that the proposal to change the acronym(s) for the certificate programs is well intentioned, but could create more issues than it solves.  There are certificates and certifications in a wide variety of fields, and the terms nearly always refer to two distinctly different things.  A certificate means that you have completed a continuing education program designed to provide some level of exposure to a body of knowledge.  These vary widely in quality and depth depending on who offers it.  Conversely, a certification is a standardized designation conferred by a professional body meant to show that the individual has attained a deeper level of understanding of that body of knowledge through study and experience.  That's why you need a certain amount of experience and/or postgraduate education in order to qualify to sit for a certification exam.  It's also why a well-designed certification exam presents questions from various levels of Bloom's taxonomy, is written with heavy involvement from the member body, and is scored in a highly standardized manner.  By convention, recognized certifications may appear along with degrees in one's professional name.  A certificate program could appear in the body of a resume under "addtional training," but not with a name and degree.  So, changing the abbreviation for the RA certificate programs (which really don't have an abbreviation at all that's listed by RAPS, at least that I can find), has the potential to dilute the value of the RAC if those abbreviations can be listed in the same way as the RAC.

-------------------------------------------
Craig A Claussen PhD, RAC
Schaumburg IL
United States
-------------------------------------------


Original Message:
Sent: 10-26-2014 14:41
From: Nupur Gangopadhyay
Subject: How to find a entry level regulatory job

Thanks lot Albert, Nupur

-------------------------------------------
Nupur Gangopadhyay Ph.D., RAC
Monroeville PA
United States
-------------------------------------------


Original Message:
Sent: 10-26-2014 11:13
From: Albert Wong
Subject: How to find a entry level regulatory job

Nupur,

I have quickly looked at your resume. Based on my 30 second review, I probably would have to pass also. It seems like you have a TON of experience, but nothing on your resume screams that you have done anything related to regulatory. I was in your same position a year ago, but as you look back in your career, everything you have done have some component of regulatory involved. you will need to modify your resume to focus on those skills that could translate into a regulatory position.

One suggestions is for you to contact a temp agency that focuses on regulatory positions. The recruiter may have open positions for someone with your experiences. The recruiter may also be able to help you re-write your resume.

There are many people who have a ton of experience that want to transition into reg, it is all about presentation. That is how you will get your foot in the door. Good luck.

Albert

-------------------------------------------
Albert Wong
Manager, Regulatory CMC
Biomarin Pharmaceutical Inc.
San Francisco CA
United States
-------------------------------------------


Original Message:
Sent: 10-21-2014 18:54
From: Nupur Gangopadhyay
Subject: How to find a entry level regulatory job

Hi members,

Recently, I have obtained a RAC certificate (Dual) with an intention of career transition. In spite of numerous application, I have not received single response. I have tried in positions where prior experience not required but no response. It seems, in this profession "no experience-----no job". I will appreciate if you can provide me any advice. I have a background in bio-medical research and reviewer for IRB. Thanks in advance for any form of assistance.

Regards,
Nupur 


-------------------------------------------
Nupur Gangopadhyay D.V.M, M.S.,Ph.D, RAC
Monroeville PA
United States
-------------------------------------------

Nupur,

The difference between "certificate" and "certification" is well-established.

See for example from ASQ:
https://asq.org/cert/resource/pdf/certification/certification-vs-certificate.pdf

Public Health
http://www.sph.umich.edu/distance/certificate_vs_certification.html

American Association of Legal Nurses
http://www.aalnc.org/?page=certificate

American Hospital Association
http://www.aha.org/certifcenter/ccresourcecenter/0906ccresourcecenter.pdf

Alzheimer Caregivers
https://ncbac.net/content/what-difference-between-certificate-course-and-professional-certification

These are only the ones having to do with biomedical regulatory and / or health care.

All have in common that a "certificate" demonstrates successful completion of coursework, while "certification" demonstrates successfully passing an assessment exam.

Both have their place in career development and it is up to the individual to select the path. 

-------------------------------------------
Jean Bigoney PHD
Managing Member
Nu Device Consulting LLC
Newport NH
United States
-------------------------------------------


Original Message:
Sent: 10-29-2014 18:35
From: Nupur Gangopadhyay
Subject: How to find a entry level regulatory job

Hi Zac,

Thanks for response. In order to make this conversation nice and crispy, you are welcome to answer next to my quarry.

1. As other members suggested does RAPS can change the nomenclature of the certificate?

2. What does attached piece of document stands for?

3. Why in the attached document and in the course advertisement, things are not written clearly? Of-course, I am talking about " this course is an online training which has no curriculum value" or " this is a continuing education program and does not confer a certificate" or any forms of of statement which will clearly explain that no certificate will be provided.

4. In the legal of view or ethical point of view does your explanation matches with attached document?

Honestly, I do not see (neither as water mark or as small letters with statuary warning) any hints of your explanation in the document issues to me. Hope I have convinced you enough regarding this issue.

Friend, nothing personal. All I am trying to do here to fix an inherent problem. 

With my best regards,

Nupur

-------------------------------------------
Nupur N. Gangopadhyay, DVM, MS, Ph.D.
Monroeville, PA
USA
-------------------------------------------

 

I agree with Jean; she made the point much more succinctly than I did earlier.  RAPS' approach is consistent with normal practice, and the two terms are generally well understood at a glance by hiring managers and recruiters.  Changing the name will put the burden on them to figure out what the candidate is talking about, which they probably won't be able to take the time to do...thus making the training of no value.

-------------------------------------------
Craig Claussen PHD, RAC
Schaumburg IL
United States
-------------------------------------------


Original Message:
Sent: 10-30-2014 07:59
From: Jean Bigoney
Subject: How to find a entry level regulatory job

Nupur,

The difference between "certificate" and "certification" is well-established.

See for example from ASQ:
https://asq.org/cert/resource/pdf/certification/certification-vs-certificate.pdf

Public Health
http://www.sph.umich.edu/distance/certificate_vs_certification.html

American Association of Legal Nurses
http://www.aalnc.org/?page=certificate

American Hospital Association
http://www.aha.org/certifcenter/ccresourcecenter/0906ccresourcecenter.pdf

Alzheimer Caregivers
https://ncbac.net/content/what-difference-between-certificate-course-and-professional-certification

These are only the ones having to do with biomedical regulatory and / or health care.

All have in common that a "certificate" demonstrates successful completion of coursework, while "certification" demonstrates successfully passing an assessment exam.

Both have their place in career development and it is up to the individual to select the path. 

-------------------------------------------
Jean Bigoney PHD
Managing Member
Nu Device Consulting LLC
Newport NH
United States
-------------------------------------------


Original Message:
Sent: 10-29-2014 18:35
From: Nupur Gangopadhyay
Subject: How to find a entry level regulatory job

Hi Zac,

Thanks for response. In order to make this conversation nice and crispy, you are welcome to answer next to my quarry.

1. As other members suggested does RAPS can change the nomenclature of the certificate?

2. What does attached piece of document stands for?

3. Why in the attached document and in the course advertisement, things are not written clearly? Of-course, I am talking about " this course is an online training which has no curriculum value" or " this is a continuing education program and does not confer a certificate" or any forms of of statement which will clearly explain that no certificate will be provided.

4. In the legal of view or ethical point of view does your explanation matches with attached document?

Honestly, I do not see (neither as water mark or as small letters with statuary warning) any hints of your explanation in the document issues to me. Hope I have convinced you enough regarding this issue.

Friend, nothing personal. All I am trying to do here to fix an inherent problem. 

With my best regards,

Nupur

-------------------------------------------
Nupur N. Gangopadhyay, DVM, MS, Ph.D.
Monroeville, PA
USA
-------------------------------------------