Regulatory Open Forum

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  • 1.  Entry Level Positions

    Posted 26-May-2017 12:18
    Hello Community, 
    I graduated with a PharmD in 2014.  I had to enter retail pharmacy for financial reasons because I could not afford the pay fellows receive since I did have to finance all of pharmacy school.  Now that I have my student loans under control, I have begun to explore careers outside of the retail setting.  After long research and much discussion with other PharmD's, I have found my calling to Regulatory Affairs.  I have attempted to enter the field and have now completed about 50% of the RAPS Dual Certificate Program.  Despite being located in a great area for Industry, greater Philadelphia area, I am having difficulty locating entry level positions.  It seems that every position posted, even those listed as entry level, are looking for candidates with at least two years of experience.  For people that were in similar positions and professionals that work in this area, what type of positions should I be looking for? I have read on forums that many people who enter RA start with drug safety positions, would this be the best path to enter industry and have side ways movement to RA?  

    any help or resources would be appreciated

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    Adam Fanelle
    Runnemede NJ
    United States
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  • 2.  RE: Entry Level Positions

    Posted 27-May-2017 11:42

    Hi, Adam.

     

    I personally started in Pharmaceutical Development for 10 years then did a lateral transfer into Regulatory, and now have been in Regulatory for 17 years.  I knew nothing about Regulatory Affairs when I started in the industry, but learned a great deal about Regulatory through writing CMC sections of INDs and CTAs, answering agency questions, and finally co-writing the CMC sections of 2 approved NDAs; all of which solidified my interest in Regulatory as a career.  I also spent a great deal of time with my medical colleagues learning about clinical protocols, endpoints, etc., giving me a more rounded drug development background making my transition into Regulatory easier.  Once in RA, I then had to learn the operational details about communicating with FDA, 1571s, inspections, etc.

     

    Besides Pharmacovigilance (PV), there are a few additional options to consider, which would utilize your PharmD background.  One option would be in a pharmaceutics/formulation development role working in either a Pharmaceutical Development/CMC function or in a Clinical Trial Materials/Supply Chain Management function.  Another option would be in Medical Affairs, helping to coordinate scientific publications of the company's clinical data, prepare presentations, facilitate prescribing physician engagements, plan Medical Advisory Boards, etc.  A third option could be Program Management working with cross-functional teams to advance candidates into and through clinical trials and marketing approvals.  All 3, would allow you to use your scientific background.  In all 3 of these roles, you would have extensive interactions with Regulatory Affairs and would be able to find ways to learn the basics of drug development and RA over a 2-3 year period.  Then, if Regulatory still appeals to you, you could seek a lateral transfer into an RA role at probably a Sr. Associate or Manager level.

     

    Good luck!

     

    Mark

    __________________________

     

    Mark A. De Rosch, PhD

    Senior Vice President,

    Regulatory Affairs, Quality Assurance, and CMC

    Akebia Therapeutics, Inc.

    245 First Street, 14th Floor

    Cambridge, MA 02142

     

    Office: (617) 871-1214

    Cell: (603) 714-5079

    Main: (617) 871-2098

    Fax: (617) 871-2099

    Email: MDeRosch@Akebia.com

    Web: www.akebia.com

    image001.png@01CF345F.B6E98B10

     

     




    Original Message


  • 3.  RE: Entry Level Positions

    Posted 31-May-2017 09:11
    this was helpful

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    Jane Awuh
    Trondheim
    Norway
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    Original Message


  • 4.  RE: Entry Level Positions

    Posted 30-May-2017 08:18
    HI Adam.

    I agree with all of these possible suggestions.  I also offer another - consider entry through work with an IRB.  This could be a full time paid position or it could even be done consulting outside of your current schedule (really depends on what you are looking for and what might be available).  Often larger hospitals and universities have these folks on staff routinely to review the medical protocols and informed consent documentation as well as significant inclusion and exclusion criteria and "cut-off" results (situations where a person is in the study but then subsequently dropped due to some unforeseen or potentially confounding reaction or co-morbidity).  I also can share with you that I did not start in regulatory - I spent the first 9+ years of my career in microbiology (both quality and R&D) and took a lateral move to Regulatory when I saw a position open up.  I will say that I have found entry into the field far easier when you enter with a current employer in a lateral move role because you have already built up an understanding of the products as well as built a track record for yourself with the company.  You might even consider trying to determine if your current retail employer has a position that might be worthwhile for your consideration - like reporting and record-keeping - this is especially true if you are a compounding pharmacy.

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


  • 5.  RE: Entry Level Positions

    Posted 10-Aug-2017 09:45
    ​Dear Adam,

    In addition to what the others suggested, I want to say keep pushing and consider other options. I am transitioning from the academia and here is my experience. 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 should also help me move more easily in to regulatory positions in the future if i 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

    Jane


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    Jane Awuh
    Trondheim
    Norway
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    Original Message


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