Regulatory Open Forum

Hello my name is Shankia Mardenborough and I am finishing up my last year at University of Maryland School of Pharmacy Masters in Regulatory Science program. I'm Discovering that, It is so difficult to find a job in the regulatory field if you don't already have years of experience under your belt. I am looking for a company or someone that would mentor me so that I can get experience. Or an internship. Has anyone else had this experience? What did you do? Can you give me pointers on what my next step should be? 

Stay Safe and Healthy
Shankia Mardenborough

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Shankia Mardenborough
Havre de Grace MD
United States
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Hi, 
Do you have a plan than includes your designated regulatory section? Drugs?  Biologics? Combo? Pre-market? Post-market? This should help you find the best mentor for your career.

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Nancy Gertlar FRAPS, RAC
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Original Message:
Sent: 03-Oct-2020 06:52
From: Shankia Mardenborough
Subject: Mentor

Hello my name is Shankia Mardenborough and I am finishing up my last year at University of Maryland School of Pharmacy Masters in Regulatory Science program. I'm Discovering that, It is so difficult to find a job in the regulatory field if you don't already have years of experience under your belt. I am looking for a company or someone that would mentor me so that I can get experience. Or an internship. Has anyone else had this experience? What did you do? Can you give me pointers on what my next step should be?

Stay Safe and Healthy
Shankia Mardenborough

------------------------------
Shankia Mardenborough
Havre de Grace MD
United States
------------------------------

Yes thank you
Drugs

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Shankia Mardenborough
Havre De Grace MD
United States
------------------------------

Original Message:
Sent: 04-Oct-2020 07:49
From: Nancy Gertlar
Subject: Mentor

Hi,
Do you have a plan than includes your designated regulatory section? Drugs?  Biologics? Combo? Pre-market? Post-market? This should help you find the best mentor for your career.

------------------------------
Nancy Gertlar FRAPS, RAC

Original Message:
Sent: 03-Oct-2020 06:52
From: Shankia Mardenborough
Subject: Mentor

Hello my name is Shankia Mardenborough and I am finishing up my last year at University of Maryland School of Pharmacy Masters in Regulatory Science program. I'm Discovering that, It is so difficult to find a job in the regulatory field if you don't already have years of experience under your belt. I am looking for a company or someone that would mentor me so that I can get experience. Or an internship. Has anyone else had this experience? What did you do? Can you give me pointers on what my next step should be?

Stay Safe and Healthy
Shankia Mardenborough

------------------------------
Shankia Mardenborough
Havre de Grace MD
United States
------------------------------

Hi,
my name is Paul Younis. I'm a master student who is getting my degree in Master of Pharmaceutical Science.  I currently work as an Inventory Coordinator/Quality specialists at Express Script/Cigna.  I have a lot of experience working in the pharmaceutical industry working. I'm looking for someone who can mentor/help me to get into regulatory affairs Jobs  market . I'm highly interested in the field but can't seem to find a entry level jobs. What qualifications  do you need to get into the job market?

Thank you,
Paul

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Paul Younis
Edgewater Park NJ
United States
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Original Message:
Sent: 03-Oct-2020 06:52
From: Shankia Mardenborough
Subject: Mentor

Hello my name is Shankia Mardenborough and I am finishing up my last year at University of Maryland School of Pharmacy Masters in Regulatory Science program. I'm Discovering that, It is so difficult to find a job in the regulatory field if you don't already have years of experience under your belt. I am looking for a company or someone that would mentor me so that I can get experience. Or an internship. Has anyone else had this experience? What did you do? Can you give me pointers on what my next step should be?

Stay Safe and Healthy
Shankia Mardenborough

------------------------------
Shankia Mardenborough
Havre de Grace MD
United States
------------------------------

This message was posted by a user wishing to remain anonymous

Hi Shankia,

I completed my Masters in RAQA last year. It is true that to get the first break in RA is often times difficult. There is always an influx and migration from internal departments to RA.
Here's are few steps I followed:
1) Search for a short term internship role. Get a linked premium account and start connecting with people of your interest in LinkedIn. It sounds a bit awkward to approach unknown people, but I got my first break in RA by approaching a VP in RA who responded to me and helped me with an internship.
2) Take up supporting RA roles : Administrative, labelling reviews , dossier compilations or support any registration work.
3) Look for short term contract roles and start from there.
4) Take assignments in allied fields like clinical research, clinical writing , validation assistant etc. (These days there are many requirements for Clinical writers since most of the firms are transitioning to MDR/IVDR )
5) With knowledge of pharmaceutical sciences you can also contribute firms in drafting and compilation of Module 3/CMC sections.

Look for consulting firms, start ups and mid sized firms. Google medical device firms and drug companies around your near vicinity. Make a long list of companies and approach them one by one. 
Keep trying and don't loose hope or feel dejected when people don't respond to you.
Hope this helps!

Best!





Original Message:
Sent: 03-Oct-2020 06:52
From: Shankia Mardenborough
Subject: Mentor

Hello my name is Shankia Mardenborough and I am finishing up my last year at University of Maryland School of Pharmacy Masters in Regulatory Science program. I'm Discovering that, It is so difficult to find a job in the regulatory field if you don't already have years of experience under your belt. I am looking for a company or someone that would mentor me so that I can get experience. Or an internship. Has anyone else had this experience? What did you do? Can you give me pointers on what my next step should be?

Stay Safe and Healthy
Shankia Mardenborough

------------------------------
Shankia Mardenborough
Havre de Grace MD
United States
------------------------------

Thank you so much this helps alot.

------------------------------
Shankia Mardenborough
Havre De Grace MD
United States
------------------------------

Original Message:
Sent: 05-Oct-2020 10:57
From: Anonymous Member
Subject: Mentor

This message was posted by a user wishing to remain anonymous

Hi Shankia,

I completed my Masters in RAQA last year. It is true that to get the first break in RA is often times difficult. There is always an influx and migration from internal departments to RA.
Here's are few steps I followed:
1) Search for a short term internship role. Get a linked premium account and start connecting with people of your interest in LinkedIn. It sounds a bit awkward to approach unknown people, but I got my first break in RA by approaching a VP in RA who responded to me and helped me with an internship.
2) Take up supporting RA roles : Administrative, labelling reviews , dossier compilations or support any registration work.
3) Look for short term contract roles and start from there.
4) Take assignments in allied fields like clinical research, clinical writing , validation assistant etc. (These days there are many requirements for Clinical writers since most of the firms are transitioning to MDR/IVDR )
5) With knowledge of pharmaceutical sciences you can also contribute firms in drafting and compilation of Module 3/CMC sections.

Look for consulting firms, start ups and mid sized firms. Google medical device firms and drug companies around your near vicinity. Make a long list of companies and approach them one by one.
Keep trying and don't loose hope or feel dejected when people don't respond to you.
Hope this helps!

Best!





Original Message:
Sent: 03-Oct-2020 06:52
From: Shankia Mardenborough
Subject: Mentor

Hello my name is Shankia Mardenborough and I am finishing up my last year at University of Maryland School of Pharmacy Masters in Regulatory Science program. I'm Discovering that, It is so difficult to find a job in the regulatory field if you don't already have years of experience under your belt. I am looking for a company or someone that would mentor me so that I can get experience. Or an internship. Has anyone else had this experience? What did you do? Can you give me pointers on what my next step should be?

Stay Safe and Healthy
Shankia Mardenborough

------------------------------
Shankia Mardenborough
Havre de Grace MD
United States
------------------------------