Regulatory Open Forum

Hello Guys!

I am currently in my 3rd year doctoral program. My project is formulation based. However, I am increasingly becoming interested in the regulatory affairs side of the whole drug development and approval cycle. I want to start somewhere but I have lots of questions in my mind. Hopefully, some of you can answer it. Your feedback will be really helpful.
1) I have heard that someone with a Ph.D. degree doesn't need any RA certification courses. Is that true?
2) How can I successfully transition from benchtop work to regulatory affairs job?
3) If I want to pursue RAC, what is the right material to study from? I see that there are a lot of books available online on this website. Also, how much time should I give myself (approximately) to study for RAC? 
4) Will Ph.D. at the end of my name give me any boost in regulatory affairs career since my PhD will be in pre-formulation/drug delivery area?

Any other advice will be much appreciated. Thank you so much!



------------------------------
Sumeet Singla
Graduate Research Assistant in PhD in Pharmaceutics Program
University of Iowa

------------------------------

I think there is a Forum around careers that might better answer, but I will take a shot (noting that I've done a little pharma and a lot of device RA)

1) technically, no one "needs" RA certification or courses. However, at times, they do help establish your seriousness about RA as a career. Additionally, they provide at least a basic understanding of the area that is helpful. That said, there are many people who have had great RA careers with nary a certification. You will need to decide what will work best for you.

2) This is a topic unto itself. By far the easiest way is to get a job at a pharma company in your technical area. Then make friends with the RA team and volunteer to help them out along the way with small projects. Then when an opening occurs (and they always will), make clear to the manager that you are interested in the opportunity. However, one can find other ways, generally through things like internships and networking.

3) I can't estimate, as it has been a while since I took it and everyone learns differently

4) My experience is that at times, yes, but it depends on your company and career goals. It is perfetly possible to be a great RA person with only a BS degree. Many companies still want higher management roles to have at least a MS. And there are a lot of companies that will value to PhD even more. That said, most of all at those level they want people who are really good at RA strategy and understand the business - so the PhD alone won't get you there. However, all other things being close, it can be a difference maker.

Good luck! It is a great field!

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN
------------------------------

Original Message:
Sent: 23-Jan-2018 23:33
From: Sumeet Singla
Subject: RACS certification course for a graduate student

Hello Guys!

I am currently in my 3rd year doctoral program. My project is formulation based. However, I am increasingly becoming interested in the regulatory affairs side of the whole drug development and approval cycle. I want to start somewhere but I have lots of questions in my mind. Hopefully, some of you can answer it. Your feedback will be really helpful.
1) I have heard that someone with a Ph.D. degree doesn't need any RA certification courses. Is that true?
2) How can I successfully transition from benchtop work to regulatory affairs job?
3) If I want to pursue RAC, what is the right material to study from? I see that there are a lot of books available online on this website. Also, how much time should I give myself (approximately) to study for RAC?
4) Will Ph.D. at the end of my name give me any boost in regulatory affairs career since my PhD will be in pre-formulation/drug delivery area?

Any other advice will be much appreciated. Thank you so much!



------------------------------
Sumeet Singla
Graduate Research Assistant in PhD in Pharmaceutics Program
University of Iowa

------------------------------

Thank you so much, Ms. Ginger. That was VERY helpful! I really appreciate it.

------------------------------
Sumeet Singla
Graduate Research Assistant in PhD in Pharmaceutic Program
University of Iowa
Iowa City IA
United States
------------------------------

Original Message:
Sent: 24-Jan-2018 08:25
From: Ginger Glaser
Subject: RACS certification course for a graduate student

I think there is a Forum around careers that might better answer, but I will take a shot (noting that I've done a little pharma and a lot of device RA)

1) technically, no one "needs" RA certification or courses. However, at times, they do help establish your seriousness about RA as a career. Additionally, they provide at least a basic understanding of the area that is helpful. That said, there are many people who have had great RA careers with nary a certification. You will need to decide what will work best for you.

2) This is a topic unto itself. By far the easiest way is to get a job at a pharma company in your technical area. Then make friends with the RA team and volunteer to help them out along the way with small projects. Then when an opening occurs (and they always will), make clear to the manager that you are interested in the opportunity. However, one can find other ways, generally through things like internships and networking.

3) I can't estimate, as it has been a while since I took it and everyone learns differently

4) My experience is that at times, yes, but it depends on your company and career goals. It is perfetly possible to be a great RA person with only a BS degree. Many companies still want higher management roles to have at least a MS. And there are a lot of companies that will value to PhD even more. That said, most of all at those level they want people who are really good at RA strategy and understand the business - so the PhD alone won't get you there. However, all other things being close, it can be a difference maker.

Good luck! It is a great field!

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN

Original Message:
Sent: 23-Jan-2018 23:33
From: Sumeet Singla
Subject: RACS certification course for a graduate student

Hello Guys!

I am currently in my 3rd year doctoral program. My project is formulation based. However, I am increasingly becoming interested in the regulatory affairs side of the whole drug development and approval cycle. I want to start somewhere but I have lots of questions in my mind. Hopefully, some of you can answer it. Your feedback will be really helpful.
1) I have heard that someone with a Ph.D. degree doesn't need any RA certification courses. Is that true?
2) How can I successfully transition from benchtop work to regulatory affairs job?
3) If I want to pursue RAC, what is the right material to study from? I see that there are a lot of books available online on this website. Also, how much time should I give myself (approximately) to study for RAC?
4) Will Ph.D. at the end of my name give me any boost in regulatory affairs career since my PhD will be in pre-formulation/drug delivery area?

Any other advice will be much appreciated. Thank you so much!



------------------------------
Sumeet Singla
Graduate Research Assistant in PhD in Pharmaceutics Program
University of Iowa

------------------------------

Adding to Ginger's comments, companies will look more on the skills than certifications. None of the global regulatory agencies require the submitters of any applications to be RAC (Regulatory Affairs Certified) but more on how the individual follows the guidelines. The role of a Regulatory Person (RP) is to provide guidance as well as define the boundaries to which a company can launch / market a product without incurring into legal / governmental implications. So, my suggestion is for you to learn more about the Regulatory field, which area and region you want specialize and then browse the websites of entities such as FDA, Health Canada, EMA, CFDA to mention few. Also, consider joining RAPS since there is a lot of information flowing either from the daily newsletters to blogs like this one where you could learn more than attending courses (courses are good but exchanging ideas is better). And working with drug formulations is actually a plus because you will have a better insight of the development process which is quite helpful when working on CMC (Chemical, Manufacturing, Control) submissions. And having a PhD shows your knowledge and commitment for accuracy which is a critical factor being in regulatory.

Hopefully this should help!

------------------------------
[Robert] [Falcone]
[Integris3Biosolutions]
[Bedminster] [NJ]
[US]
------------------------------

Original Message:
Sent: 23-Jan-2018 23:33
From: Sumeet Singla
Subject: RACS certification course for a graduate student

Hello Guys!

I am currently in my 3rd year doctoral program. My project is formulation based. However, I am increasingly becoming interested in the regulatory affairs side of the whole drug development and approval cycle. I want to start somewhere but I have lots of questions in my mind. Hopefully, some of you can answer it. Your feedback will be really helpful.
1) I have heard that someone with a Ph.D. degree doesn't need any RA certification courses. Is that true?
2) How can I successfully transition from benchtop work to regulatory affairs job?
3) If I want to pursue RAC, what is the right material to study from? I see that there are a lot of books available online on this website. Also, how much time should I give myself (approximately) to study for RAC?
4) Will Ph.D. at the end of my name give me any boost in regulatory affairs career since my PhD will be in pre-formulation/drug delivery area?

Any other advice will be much appreciated. Thank you so much!



------------------------------
Sumeet Singla
Graduate Research Assistant in PhD in Pharmaceutics Program
University of Iowa

------------------------------

Mr. Robert, I have already joined RAPS and I am looking forward to <g class="gr_ gr_68 gr-alert gr_gramm gr_inline_cards gr_run_anim Grammar multiReplace" id="68" data-gr-id="68">learn</g> more about this interesting field. Thank you for devoting your valuable time to answer my questions.

------------------------------
Sumeet Singla
Graduate Research Assistant in PhD in Pharmaceutic Program
University of Iowa
Iowa City IA
United States
------------------------------

Original Message:
Sent: 24-Jan-2018 08:56
From: Robert Falcone
Subject: RACS certification course for a graduate student

Adding to Ginger's comments, companies will look more on the skills than certifications. None of the global regulatory agencies require the submitters of any applications to be RAC (Regulatory Affairs Certified) but more on how the individual follows the guidelines. The role of a Regulatory Person (RP) is to provide guidance as well as define the boundaries to which a company can launch / market a product without incurring into legal / governmental implications. So, my suggestion is for you to learn more about the Regulatory field, which area and region you want specialize and then browse the websites of entities such as FDA, Health Canada, EMA, CFDA to mention few. Also, consider joining RAPS since there is a lot of information flowing either from the daily newsletters to blogs like this one where you could learn more than attending courses (courses are good but exchanging ideas is better). And working with drug formulations is actually a plus because you will have a better insight of the development process which is quite helpful when working on CMC (Chemical, Manufacturing, Control) submissions. And having a PhD shows your knowledge and commitment for accuracy which is a critical factor being in regulatory.

Hopefully this should help!

------------------------------
[Robert] [Falcone]
[Integris3Biosolutions]
[Bedminster] [NJ]
[US]

Original Message:
Sent: 23-Jan-2018 23:33
From: Sumeet Singla
Subject: RACS certification course for a graduate student

Hello Guys!

I am currently in my 3rd year doctoral program. My project is formulation based. However, I am increasingly becoming interested in the regulatory affairs side of the whole drug development and approval cycle. I want to start somewhere but I have lots of questions in my mind. Hopefully, some of you can answer it. Your feedback will be really helpful.
1) I have heard that someone with a Ph.D. degree doesn't need any RA certification courses. Is that true?
2) How can I successfully transition from benchtop work to regulatory affairs job?
3) If I want to pursue RAC, what is the right material to study from? I see that there are a lot of books available online on this website. Also, how much time should I give myself (approximately) to study for RAC?
4) Will Ph.D. at the end of my name give me any boost in regulatory affairs career since my PhD will be in pre-formulation/drug delivery area?

Any other advice will be much appreciated. Thank you so much!



------------------------------
Sumeet Singla
Graduate Research Assistant in PhD in Pharmaceutics Program
University of Iowa

------------------------------

You do not need a specific level of degree to work in regulatory affairs or need certification supported by a higher education degree, vice versa for working in regulatory affairs.  As mentioned, getting certification or taking additional courses in regulatory affairs helps to show a potential employer that you are serious - enough to spend the energy and time to do more.

Obtain the Fundamentals of Regulatory Affairs book to help you study for the RAC exam.  This is definitely a needed tool, beyond all of the regulations, standards, and other materials, as it has all of the updated information that would be contained in the exam.  Finding a study group is also helpful especially if the group has a mix of medical device people and pharmaceutical people.  As much time as you need !  It is a closed-bool exam that you need to make sure you are prepared as every person is different in their study methods.

Ph.D. at the end of your name shows you have the education, but when I am looking for individuals for positions in regulatory affairs it is all about the experience and then competence observed through the interview.  I does add credential to what you may be looking at, but being a motivated individual, learning new things, and gaining the experience is crucial.

------------------------------
Richard Vincins RAC
Vice President Regulatory Affairs
------------------------------

Original Message:
Sent: 23-Jan-2018 23:33
From: Sumeet Singla
Subject: RACS certification course for a graduate student

Hello Guys!

I am currently in my 3rd year doctoral program. My project is formulation based. However, I am increasingly becoming interested in the regulatory affairs side of the whole drug development and approval cycle. I want to start somewhere but I have lots of questions in my mind. Hopefully, some of you can answer it. Your feedback will be really helpful.
1) I have heard that someone with a Ph.D. degree doesn't need any RA certification courses. Is that true?
2) How can I successfully transition from benchtop work to regulatory affairs job?
3) If I want to pursue RAC, what is the right material to study from? I see that there are a lot of books available online on this website. Also, how much time should I give myself (approximately) to study for RAC?
4) Will Ph.D. at the end of my name give me any boost in regulatory affairs career since my PhD will be in pre-formulation/drug delivery area?

Any other advice will be much appreciated. Thank you so much!



------------------------------
Sumeet Singla
Graduate Research Assistant in PhD in Pharmaceutics Program
University of Iowa

------------------------------

Mr. Richard, thank you much for your valuable input. Everyone has <g class="gr_ gr_109 gr-alert gr_gramm gr_hide gr_inline_cards gr_run_anim Grammar only-ins multiReplace replaceWithoutSep replaceWithoutSep" id="109" data-gr-id="109">same</g> underlying message that RAC is not needed but it definitely does show seriousness to future employers.
I am definitely branching in this area in the next one year, either by studying or by gaining internship experience.

------------------------------
Sumeet Singla
Graduate Research Assistant in PhD in Pharmaceutic Program
University of Iowa
Iowa City IA
United States
------------------------------

Original Message:
Sent: 24-Jan-2018 09:24
From: Richard Vincins
Subject: RACS certification course for a graduate student

You do not need a specific level of degree to work in regulatory affairs or need certification supported by a higher education degree, vice versa for working in regulatory affairs.  As mentioned, getting certification or taking additional courses in regulatory affairs helps to show a potential employer that you are serious - enough to spend the energy and time to do more.

Obtain the Fundamentals of Regulatory Affairs book to help you study for the RAC exam.  This is definitely a needed tool, beyond all of the regulations, standards, and other materials, as it has all of the updated information that would be contained in the exam.  Finding a study group is also helpful especially if the group has a mix of medical device people and pharmaceutical people.  As much time as you need !  It is a closed-bool exam that you need to make sure you are prepared as every person is different in their study methods.

Ph.D. at the end of your name shows you have the education, but when I am looking for individuals for positions in regulatory affairs it is all about the experience and then competence observed through the interview.  I does add credential to what you may be looking at, but being a motivated individual, learning new things, and gaining the experience is crucial.

------------------------------
Richard Vincins RAC
Vice President Regulatory Affairs

Original Message:
Sent: 23-Jan-2018 23:33
From: Sumeet Singla
Subject: RACS certification course for a graduate student

Hello Guys!

I am currently in my 3rd year doctoral program. My project is formulation based. However, I am increasingly becoming interested in the regulatory affairs side of the whole drug development and approval cycle. I want to start somewhere but I have lots of questions in my mind. Hopefully, some of you can answer it. Your feedback will be really helpful.
1) I have heard that someone with a Ph.D. degree doesn't need any RA certification courses. Is that true?
2) How can I successfully transition from benchtop work to regulatory affairs job?
3) If I want to pursue RAC, what is the right material to study from? I see that there are a lot of books available online on this website. Also, how much time should I give myself (approximately) to study for RAC?
4) Will Ph.D. at the end of my name give me any boost in regulatory affairs career since my PhD will be in pre-formulation/drug delivery area?

Any other advice will be much appreciated. Thank you so much!



------------------------------
Sumeet Singla
Graduate Research Assistant in PhD in Pharmaceutics Program
University of Iowa

------------------------------