Regulatory Open Forum

Dear Everyone,

I work in the academia now but want to transition into RA so I got enrolled in the RAPS Pharma & Medical Devices dual program in February and became a RAPS member. I am halfway through the course and then decided to start applying for jobs. I got a mail for an interview from a big Pharma Company today for the position of a regulatory affairs associate. Exciting!

Now I am as green as can be in this field but determined to be come an expert :). So my question today to you all is what can I expect in this interview?

Any advice and experiences would be much appreciated.

Thank you for your time.

Jane

------------------------------
Jane Awuh
Trondheim
Norway
------------------------------

Dear Jane,

 

pharma regulatory processes concerning product documentation are

·         marketing authorisation applications,

·         change control processes finally taking place between companies and health authorities.

·         process validations to ensure that the company procedures are in line with the applicable regulations (inspections)

·         corrective and preventive actions (recalls, changes to regulations).

 

The target is to ensure, only safe and effective products may be marketed. In case of marketed products, the aim is to ensure, only reproducible Products ares manufactured during their life-cycle, which meet the specifications described in the marketing authorisation.

The changes are initiated by the manufacturing facility, medical department, safety department, legal department mostly.

Here are the changes: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001782.jsp&mid=WC0b01ac0580b18c7b

in case you expect to be employed in

·       an affiliate, you are going to be involved in a special change control process, as middleman between company HQs and Health Authority,

·         corporate regulatory, you will be involved in the same change control process, as the one controlling/generating the process towards the affiliates,

·        a manufacturing facility, you will be involved in the same change control process, as the one controlling/generating the process towards corporate regulatory,

·         in all cases you will be a special project manager and/or you need to compile relevant documents.

·         You may start here: https://legemiddelverket.no/english/regulatory-affairs

The job description will guide you about required skills and experience.  

Regards

Peter

------------------------------
Peter Miko M.D.
ArtPharm
Gyermely
Hungary
------------------------------

Original Message:
Sent: 25-Mar-2017 10:29
From: Jane Awuh
Subject: Regulatory Interview

Dear Everyone,

I work in the academia now but want to transition into RA so I got enrolled in the RAPS Pharma & Medical Devices dual program in February and became a RAPS member. I am halfway through the course and then decided to start applying for jobs. I got a mail for an interview from a big Pharma Company today for the position of a regulatory affairs associate. Exciting!

Now I am as green as can be in this field but determined to be come an expert :). So my question today to you all is what can I expect in this interview?

Any advice and experiences would be much appreciated.

Thank you for your time.

Jane

------------------------------
Jane Awuh
Trondheim
Norway
------------------------------

Dear Jane 

It would depend on the combination of the following :
1- Industry (Pharma, Biotech or MD) 
2- Type of company (Manufacturing , service provider) 
3- Company size (small, intermediate) which will affect the organisation structure and hence the RA functional units 
4- The post (local, Global, innovative company, Generic company, ....)

To make it simple, generally you will proceed with the first personal skills questions like (introduce your self, tell a conflict you solved?, .... etc)

Then each there will be a specialised type of questions that will be depending on the combination of the above 4 points which will required a preparation for each case. 

For example, If we talk about a multinational manufacturing company working in Biological products and the post is related to Canada, So you have to prepare for the Canadian regulatory structure for the Biological products including the comparison between what is characteristic to Canada and what is common with other regional regulations (EU, USA) 

Hope this is useful 

Best of luck 

------------------------------
Ahmed Abouelnour
Etobicoke ON
Canada
------------------------------

Original Message:
Sent: 25-Mar-2017 10:29
From: Jane Awuh
Subject: Regulatory Interview

Dear Everyone,

I work in the academia now but want to transition into RA so I got enrolled in the RAPS Pharma & Medical Devices dual program in February and became a RAPS member. I am halfway through the course and then decided to start applying for jobs. I got a mail for an interview from a big Pharma Company today for the position of a regulatory affairs associate. Exciting!

Now I am as green as can be in this field but determined to be come an expert :). So my question today to you all is what can I expect in this interview?

Any advice and experiences would be much appreciated.

Thank you for your time.

Jane

------------------------------
Jane Awuh
Trondheim
Norway
------------------------------

Thank you people! All useful info! And nice resources link too Peter.
Jane

------------------------------
Jane Awuh
Trondheim
Norway
------------------------------

Original Message:
Sent: 25-Mar-2017 10:29
From: Jane Awuh
Subject: Regulatory Interview

Dear Everyone,

I work in the academia now but want to transition into RA so I got enrolled in the RAPS Pharma & Medical Devices dual program in February and became a RAPS member. I am halfway through the course and then decided to start applying for jobs. I got a mail for an interview from a big Pharma Company today for the position of a regulatory affairs associate. Exciting!

Now I am as green as can be in this field but determined to be come an expert :). So my question today to you all is what can I expect in this interview?

Any advice and experiences would be much appreciated.

Thank you for your time.

Jane

------------------------------
Jane Awuh
Trondheim
Norway
------------------------------

Hi Jane.

While I completely agree with what Peter and Ahmad noted I will provide this from a hiring-manager's perspective:

Obviously the hiring team has seen your resume and they know that you don't have "on-point" experience in terms of the fact that you have spent (from what I gather based on your original post) a significant portion of, if not your entire, professional career in academia.  That's usually fine but you need to be truly prepared to explain to a hiring manager how your current experience can relate to issues in regulatory.  For example, I am a firm believer in not hiring someone exactly like me with the same experience and knowledge as I have.  That becomes duplicative and a waste of a position.  So you might be best prepared to relate instances where you needed to respond to particular issues that raise similar, albeit different, specifics.  For an example, if someone were to requests information on how you would handle yourself during an inspection with a competent authority, you might consider how you have responded to inspections of grant audits or similar.

------------------------------
Victor Mencarelli
Director - Regulatory Affairs
Hain Celestial Group
United States
------------------------------

Original Message:
Sent: 25-Mar-2017 10:29
From: Jane Awuh
Subject: Regulatory Interview

Dear Everyone,

I work in the academia now but want to transition into RA so I got enrolled in the RAPS Pharma & Medical Devices dual program in February and became a RAPS member. I am halfway through the course and then decided to start applying for jobs. I got a mail for an interview from a big Pharma Company today for the position of a regulatory affairs associate. Exciting!

Now I am as green as can be in this field but determined to be come an expert :). So my question today to you all is what can I expect in this interview?

Any advice and experiences would be much appreciated.

Thank you for your time.

Jane

------------------------------
Jane Awuh
Trondheim
Norway
------------------------------

Makes a lot of sense, and couldn't agree more. Thanks Victor.
Jane

------------------------------
Jane Awuh
Trondheim
Norway
------------------------------

Original Message:
Sent: 27-Mar-2017 07:46
From: Victor Mencarelli
Subject: Regulatory Interview

Hi Jane.

While I completely agree with what Peter and Ahmad noted I will provide this from a hiring-manager's perspective:

Obviously the hiring team has seen your resume and they know that you don't have "on-point" experience in terms of the fact that you have spent (from what I gather based on your original post) a significant portion of, if not your entire, professional career in academia.  That's usually fine but you need to be truly prepared to explain to a hiring manager how your current experience can relate to issues in regulatory.  For example, I am a firm believer in not hiring someone exactly like me with the same experience and knowledge as I have.  That becomes duplicative and a waste of a position.  So you might be best prepared to relate instances where you needed to respond to particular issues that raise similar, albeit different, specifics.  For an example, if someone were to requests information on how you would handle yourself during an inspection with a competent authority, you might consider how you have responded to inspections of grant audits or similar.

------------------------------
Victor Mencarelli
Director - Regulatory Affairs
Hain Celestial Group
United States
------------------------------

Original Message:
Sent: 25-Mar-2017 10:29
From: Jane Awuh
Subject: Regulatory Interview

Dear Everyone,

I work in the academia now but want to transition into RA so I got enrolled in the RAPS Pharma & Medical Devices dual program in February and became a RAPS member. I am halfway through the course and then decided to start applying for jobs. I got a mail for an interview from a big Pharma Company today for the position of a regulatory affairs associate. Exciting!

Now I am as green as can be in this field but determined to be come an expert :). So my question today to you all is what can I expect in this interview?

Any advice and experiences would be much appreciated.

Thank you for your time.

Jane

------------------------------
Jane Awuh
Trondheim
Norway
------------------------------

Original Message------

Dear Everyone,

I work in the academia now but want to transition into RA so I got enrolled in the RAPS Pharma & Medical Devices dual program in February and became a RAPS member. I am halfway through the course and then decided to start applying for jobs. I got a mail for an interview from a big Pharma Company today for the position of a regulatory affairs associate. Exciting!

Now I am as green as can be in this field but determined to be come an expert :). So my question today to you all is what can I expect in this interview?

Any advice and experiences would be much appreciated.

Thank you for your time.

Jane

------------------------------
Jane Awuh
Trondheim
Norway
------------------------------

Thanks for the detailed response too David.
Will do my home work :)
Jane

------------------------------
Jane Awuh
Trondheim
Norway
------------------------------

Original Message:
Sent: 27-Mar-2017 09:11
From: David Lim
Subject: Regulatory Interview

Jane,

In view of your current position in academia transitioning to RA in pharma

Please consider the following.

If I am a hiring manager, I would try to learn about you during the interview for the following.

First I won't ask you about technical questions as I can train you for technical matters on a needed basis.

I will try to learn whether you are kind, trainable, and can do the work with minimum supervision. In other words, whether you can be trainable to be ready, willing and able to get the job done.

Questions I will ask - I would be asking the following with few reasons.  I would care more about how you answer than your actual answers.

Q1: how did you learn about this position?

Q2: Can you tell me your career goals for the next year or few years?

Q3: What would you do when you have free time?  

This is what I'd like to hear from you regarding question #3.  When I (Jane) have some free time, I would invest my time and make an effort to learn new things related to my job function and then apply what I've learned so that I can do and perform better.  I will always try to improve what I do and how I do under my supervisor's guidance. 

Q4: Under time pressure, how do you manage your stress?

Please have one or two questions ready to ask to the hiring manager.  For example:

Do you offer career development opportunity? 

Homework: stand straight before mirror and practice to give nice, kind smile. Get dressed up for the day!  Read your job description few times and learn about the company including "mission and purpose" and products. 

Good luck!

Thank you.

s/ David

______________________________________________

Dr. David Lim, Ph.D., RAC, ASQ-CQA 

REGULATORY DOCTOR

http://www.regulatorydoctor.US

Phone (Toll-Free): 1-(800) 321-8567

E-mail:  David@RegulatoryDoctor.US

NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.

Hi again Everyone,

Just a follow-up on this topic of interview. I feel quite frustrated that my said interview was cancelled because some of company processes apparenlty stopped working and I will be contacted again to reshedule as soon as possible. It's more than 2 months now and despite 3 attempts to find out the current status, I have not received any response. That is disheartening especially when you already start to warm up to a company. I also hear that big Pharma Companies move like big ships :) Still hoping they get back to me.

On the bright side I have completed my course and continue to apply for relevant positions. I still see that I could definitely use some hands-on industry experience even if to just supplement my RAPS certificate. I am thus open to internships (tasks) even voluntary, both remote and on-site where possible, if anyone knows or can recommend some.

Happy to hear any more ideas on this issue, anything to be more attractive.

Thanks

Jane
PS: Unlike before, I have been doing a great deal of networking recently which is great.

------------------------------
Jane Awuh
Trondheim
Norway
------------------------------

Original Message:
Sent: 25-Mar-2017 10:29
From: Jane Awuh
Subject: Regulatory Interview

Dear Everyone,

I work in the academia now but want to transition into RA so I got enrolled in the RAPS Pharma & Medical Devices dual program in February and became a RAPS member. I am halfway through the course and then decided to start applying for jobs. I got a mail for an interview from a big Pharma Company today for the position of a regulatory affairs associate. Exciting!

Now I am as green as can be in this field but determined to be come an expert :). So my question today to you all is what can I expect in this interview?

Any advice and experiences would be much appreciated.

Thank you for your time.

Jane

------------------------------
Jane Awuh
Trondheim
Norway
------------------------------

Hi, Jane. Please stay engaged. RAPS has always been strong on helping transitions into the regulatory profession.  If you can attend the Annual "Convergence," conference in September, there is lots of information sharing and sessions that will help you prepare.

------------------------------
Andrea Chamblee Esq., RAC, FRAPS

This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and do not necessarily represent the official views of the agency or the United States. Consult the Agency for an official position.

Silver Spring MD
United States
------------------------------

Original Message:
Sent: 31-May-2017 09:05
From: Jane Awuh
Subject: Regulatory Interview

Hi again Everyone,

Just a follow-up on this topic of interview. I feel quite frustrated that my said interview was cancelled because some of company processes apparenlty stopped working and I will be contacted again to reshedule as soon as possible. It's more than 2 months now and despite 3 attempts to find out the current status, I have not received any response. That is disheartening especially when you already start to warm up to a company. I also hear that big Pharma Companies move like big ships :) Still hoping they get back to me.

On the bright side I have completed my course and continue to apply for relevant positions. I still see that I could definitely use some hands-on industry experience even if to just supplement my RAPS certificate. I am thus open to internships (tasks) even voluntary, both remote and on-site where possible, if anyone knows or can recommend some.

Happy to hear any more ideas on this issue, anything to be more attractive.

Thanks

Jane
PS: Unlike before, I have been doing a great deal of networking recently which is great.

------------------------------
Jane Awuh
Trondheim
Norway
------------------------------

Original Message:
Sent: 25-Mar-2017 10:29
From: Jane Awuh
Subject: Regulatory Interview

Dear Everyone,

I work in the academia now but want to transition into RA so I got enrolled in the RAPS Pharma & Medical Devices dual program in February and became a RAPS member. I am halfway through the course and then decided to start applying for jobs. I got a mail for an interview from a big Pharma Company today for the position of a regulatory affairs associate. Exciting!

Now I am as green as can be in this field but determined to be come an expert :). So my question today to you all is what can I expect in this interview?

Any advice and experiences would be much appreciated.

Thank you for your time.

Jane

------------------------------
Jane Awuh
Trondheim
Norway
------------------------------

Original Message------

Hi again Everyone,

Just a follow-up on this topic of interview. I feel quite frustrated that my said interview was cancelled because some of company processes apparenlty stopped working and I will be contacted again to reshedule as soon as possible. It's more than 2 months now and despite 3 attempts to find out the current status, I have not received any response. That is disheartening especially when you already start to warm up to a company. I also hear that big Pharma Companies move like big ships :) Still hoping they get back to me.

On the bright side I have completed my course and continue to apply for relevant positions. I still see that I could definitely use some hands-on industry experience even if to just supplement my RAPS certificate. I am thus open to internships (tasks) even voluntary, both remote and on-site where possible, if anyone knows or can recommend some.

Happy to hear any more ideas on this issue, anything to be more attractive.

Thanks

Jane
PS: Unlike before, I have been doing a great deal of networking recently which is great.

------------------------------
Jane Awuh
Trondheim
Norway
------------------------------

​Updating again and hoping my experience would help others looking to transition!

I never got called back for the last interview I talked about earlier, so technically still waiting! But... I started the RAPS course in February and completed it in May and in July I got a job offer as a process developer in a medical device company (I applied for the job right after I completed the course). It was very important to the hiring manager that I had completed the course and I showed knowlegde and enthusiam. The position will focus on improvement of manufacturing processes and QMS at the intersection of manufacturing, marketing and regulatory! I believe there could not be a better way to get in, to get a feel and be exposed to all these different aspects surrounding device/drug development. This I am hoping should also help me move more easily in to regulatory positions in the future if I still wanted to. I am looking forward to the exciting new challenges!

So long and short, it just might be easier and even better to consider other entry positions for a start. And it definitely helped for me, to have done the RAPS course!

Good luck everyone else going down this road!
And a huge thanks to all who have been supportive here and privately.

I appreciate.

Jane

------------------------------
Jane Awuh
Trondheim
Norway
------------------------------

Original Message:
Sent: 31-May-2017 09:05
From: Jane Awuh
Subject: Regulatory Interview

Hi again Everyone,

Just a follow-up on this topic of interview. I feel quite frustrated that my said interview was cancelled because some of company processes apparenlty stopped working and I will be contacted again to reshedule as soon as possible. It's more than 2 months now and despite 3 attempts to find out the current status, I have not received any response. That is disheartening especially when you already start to warm up to a company. I also hear that big Pharma Companies move like big ships :) Still hoping they get back to me.

On the bright side I have completed my course and continue to apply for relevant positions. I still see that I could definitely use some hands-on industry experience even if to just supplement my RAPS certificate. I am thus open to internships (tasks) even voluntary, both remote and on-site where possible, if anyone knows or can recommend some.

Happy to hear any more ideas on this issue, anything to be more attractive.

Thanks

Jane
PS: Unlike before, I have been doing a great deal of networking recently which is great.

------------------------------
Jane Awuh
Trondheim
Norway

Original Message:
Sent: 25-Mar-2017 10:29
From: Jane Awuh
Subject: Regulatory Interview

Dear Everyone,

I work in the academia now but want to transition into RA so I got enrolled in the RAPS Pharma & Medical Devices dual program in February and became a RAPS member. I am halfway through the course and then decided to start applying for jobs. I got a mail for an interview from a big Pharma Company today for the position of a regulatory affairs associate. Exciting!

Now I am as green as can be in this field but determined to be come an expert :). So my question today to you all is what can I expect in this interview?

Any advice and experiences would be much appreciated.

Thank you for your time.

Jane

------------------------------
Jane Awuh
Trondheim
Norway
------------------------------

​Congratulations on your new job!

I think you made a wise decision.  I think sometimes people get too focused on "getting into Regulatory," so they do not consider other opportunities.  I think the important thing is to "get into regulated," which is to say, to get into a company that is regulated.  It is much easier to get into Regulatory from inside regulated industry than from the outside.  It is also easier to get into Regulatory if you have experience in regulated industry and in a regulated company.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 10-Aug-2017 09:55
From: Jane Awuh
Subject: Regulatory Interview

​Updating again and hoping my experience would help others looking to transition!

I never got called back for the last interview I talked about earlier, so technically still waiting! But... I started the RAPS course in February and completed it in May and in July I got a job offer as a process developer in a medical device company (I applied for the job right after I completed the course). It was very important to the hiring manager that I had completed the course and I showed knowlegde and enthusiam. The position will focus on improvement of manufacturing processes and QMS at the intersection of manufacturing, marketing and regulatory! I believe there could not be a better way to get in, to get a feel and be exposed to all these different aspects surrounding device/drug development. This I am hoping should also help me move more easily in to regulatory positions in the future if I still wanted to. I am looking forward to the exciting new challenges!

So long and short, it just might be easier and even better to consider other entry positions for a start. And it definitely helped for me, to have done the RAPS course!

Good luck everyone else going down this road!
And a huge thanks to all who have been supportive here and privately.

I appreciate.

Jane

------------------------------
Jane Awuh
Trondheim
Norway

Original Message:
Sent: 31-May-2017 09:05
From: Jane Awuh
Subject: Regulatory Interview

Hi again Everyone,

Just a follow-up on this topic of interview. I feel quite frustrated that my said interview was cancelled because some of company processes apparenlty stopped working and I will be contacted again to reshedule as soon as possible. It's more than 2 months now and despite 3 attempts to find out the current status, I have not received any response. That is disheartening especially when you already start to warm up to a company. I also hear that big Pharma Companies move like big ships :) Still hoping they get back to me.

On the bright side I have completed my course and continue to apply for relevant positions. I still see that I could definitely use some hands-on industry experience even if to just supplement my RAPS certificate. I am thus open to internships (tasks) even voluntary, both remote and on-site where possible, if anyone knows or can recommend some.

Happy to hear any more ideas on this issue, anything to be more attractive.

Thanks

Jane
PS: Unlike before, I have been doing a great deal of networking recently which is great.

------------------------------
Jane Awuh
Trondheim
Norway

Original Message:
Sent: 25-Mar-2017 10:29
From: Jane Awuh
Subject: Regulatory Interview

Dear Everyone,

I work in the academia now but want to transition into RA so I got enrolled in the RAPS Pharma & Medical Devices dual program in February and became a RAPS member. I am halfway through the course and then decided to start applying for jobs. I got a mail for an interview from a big Pharma Company today for the position of a regulatory affairs associate. Exciting!

Now I am as green as can be in this field but determined to be come an expert :). So my question today to you all is what can I expect in this interview?

Any advice and experiences would be much appreciated.

Thank you for your time.

Jane

------------------------------
Jane Awuh
Trondheim
Norway
------------------------------

​I couldn't agree more with Julie's point.  I started my career (as many other people I know) in a quality role that naturally led to regulatory opportunities.  However, had I tried to push my way into regulatory to start with I likely would have been very disappointed with the results.  Having the "regulated" background from my quality experience I was able to not only transition at my initial employer from QC to regulatory but also managed the transition a lot more fluidly since I knew the products, I knew the personalities, and more importantly I knew the requirements for the products as well. 

I see many people wanting to "break into" regulatory from other fields and interests, but I always try to caution them to get their feet in the door in the industry and then work to get into regulatory.  As a prior colleague of mine once said - regulatory is 5% book smarts, 3% negotiating skills, 2% knowledge of where to look for things, and 150% experiential!

------------------------------
Victor Mencarelli
Director - Regulatory Affairs
Hain Celestial Group
United States
------------------------------

Original Message:
Sent: 10-Aug-2017 10:01
From: Julie Omohundro
Subject: Regulatory Interview

​Congratulations on your new job!

I think you made a wise decision.  I think sometimes people get too focused on "getting into Regulatory," so they do not consider other opportunities.  I think the important thing is to "get into regulated," which is to say, to get into a company that is regulated.  It is much easier to get into Regulatory from inside regulated industry than from the outside.  It is also easier to get into Regulatory if you have experience in regulated industry and in a regulated company.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 10-Aug-2017 09:55
From: Jane Awuh
Subject: Regulatory Interview

​Updating again and hoping my experience would help others looking to transition!

I never got called back for the last interview I talked about earlier, so technically still waiting! But... I started the RAPS course in February and completed it in May and in July I got a job offer as a process developer in a medical device company (I applied for the job right after I completed the course). It was very important to the hiring manager that I had completed the course and I showed knowlegde and enthusiam. The position will focus on improvement of manufacturing processes and QMS at the intersection of manufacturing, marketing and regulatory! I believe there could not be a better way to get in, to get a feel and be exposed to all these different aspects surrounding device/drug development. This I am hoping should also help me move more easily in to regulatory positions in the future if I still wanted to. I am looking forward to the exciting new challenges!

So long and short, it just might be easier and even better to consider other entry positions for a start. And it definitely helped for me, to have done the RAPS course!

Good luck everyone else going down this road!
And a huge thanks to all who have been supportive here and privately.

I appreciate.

Jane

------------------------------
Jane Awuh
Trondheim
Norway

Original Message:
Sent: 31-May-2017 09:05
From: Jane Awuh
Subject: Regulatory Interview

Hi again Everyone,

Just a follow-up on this topic of interview. I feel quite frustrated that my said interview was cancelled because some of company processes apparenlty stopped working and I will be contacted again to reshedule as soon as possible. It's more than 2 months now and despite 3 attempts to find out the current status, I have not received any response. That is disheartening especially when you already start to warm up to a company. I also hear that big Pharma Companies move like big ships :) Still hoping they get back to me.

On the bright side I have completed my course and continue to apply for relevant positions. I still see that I could definitely use some hands-on industry experience even if to just supplement my RAPS certificate. I am thus open to internships (tasks) even voluntary, both remote and on-site where possible, if anyone knows or can recommend some.

Happy to hear any more ideas on this issue, anything to be more attractive.

Thanks

Jane
PS: Unlike before, I have been doing a great deal of networking recently which is great.

------------------------------
Jane Awuh
Trondheim
Norway

Original Message:
Sent: 25-Mar-2017 10:29
From: Jane Awuh
Subject: Regulatory Interview

Dear Everyone,

I work in the academia now but want to transition into RA so I got enrolled in the RAPS Pharma & Medical Devices dual program in February and became a RAPS member. I am halfway through the course and then decided to start applying for jobs. I got a mail for an interview from a big Pharma Company today for the position of a regulatory affairs associate. Exciting!

Now I am as green as can be in this field but determined to be come an expert :). So my question today to you all is what can I expect in this interview?

Any advice and experiences would be much appreciated.

Thank you for your time.

Jane

------------------------------
Jane Awuh
Trondheim
Norway
------------------------------

Congrats Jane!

------------------------------
Bhupinder Singh
San Jose CA
United States
------------------------------

Original Message:
Sent: 10-Aug-2017 09:55
From: Jane Awuh
Subject: Regulatory Interview

​Updating again and hoping my experience would help others looking to transition!

I never got called back for the last interview I talked about earlier, so technically still waiting! But... I started the RAPS course in February and completed it in May and in July I got a job offer as a process developer in a medical device company (I applied for the job right after I completed the course). It was very important to the hiring manager that I had completed the course and I showed knowlegde and enthusiam. The position will focus on improvement of manufacturing processes and QMS at the intersection of manufacturing, marketing and regulatory! I believe there could not be a better way to get in, to get a feel and be exposed to all these different aspects surrounding device/drug development. This I am hoping should also help me move more easily in to regulatory positions in the future if I still wanted to. I am looking forward to the exciting new challenges!

So long and short, it just might be easier and even better to consider other entry positions for a start. And it definitely helped for me, to have done the RAPS course!

Good luck everyone else going down this road!
And a huge thanks to all who have been supportive here and privately.

I appreciate.

Jane

------------------------------
Jane Awuh
Trondheim
Norway

Original Message:
Sent: 31-May-2017 09:05
From: Jane Awuh
Subject: Regulatory Interview

Hi again Everyone,

Just a follow-up on this topic of interview. I feel quite frustrated that my said interview was cancelled because some of company processes apparenlty stopped working and I will be contacted again to reshedule as soon as possible. It's more than 2 months now and despite 3 attempts to find out the current status, I have not received any response. That is disheartening especially when you already start to warm up to a company. I also hear that big Pharma Companies move like big ships :) Still hoping they get back to me.

On the bright side I have completed my course and continue to apply for relevant positions. I still see that I could definitely use some hands-on industry experience even if to just supplement my RAPS certificate. I am thus open to internships (tasks) even voluntary, both remote and on-site where possible, if anyone knows or can recommend some.

Happy to hear any more ideas on this issue, anything to be more attractive.

Thanks

Jane
PS: Unlike before, I have been doing a great deal of networking recently which is great.

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Jane Awuh
Trondheim
Norway

Original Message:
Sent: 25-Mar-2017 10:29
From: Jane Awuh
Subject: Regulatory Interview

Dear Everyone,

I work in the academia now but want to transition into RA so I got enrolled in the RAPS Pharma & Medical Devices dual program in February and became a RAPS member. I am halfway through the course and then decided to start applying for jobs. I got a mail for an interview from a big Pharma Company today for the position of a regulatory affairs associate. Exciting!

Now I am as green as can be in this field but determined to be come an expert :). So my question today to you all is what can I expect in this interview?

Any advice and experiences would be much appreciated.

Thank you for your time.

Jane

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Jane Awuh
Trondheim
Norway
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