Regulatory Open Forum

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  • 1.  How to Break Into the Reg Field

    This message was posted by a user wishing to remain anonymous
    Posted 16 days ago
    This message was posted by a user wishing to remain anonymous

    Hi all,

    It's been about 3 years after I received my undergraduate degree in biomedical engineering. I also wanted to work in regulatory, specifically regulatory affairs for medical devices. However, I had some personal health problems right when I was graduating. This might I needed to stay closer to home, so I had a narrower range for jobs. I am fortunate to have a job as a clinical research associate for a hosptial's oncology department. Although I love this job, I want to pursue my dream of working in reg affairs. 

    I'm thinking about taking the RAC exam after a expert in reg affairs recommended it. I also applied and was accepted into Johns Hopkins masters in regulatory science. Should I pursue this masters?

    I'm also applying for more quality assurance and regulatory focused jobs but no luck yet.

    Given my degree and experience, what is the best way for me to market myself to companies?

    Thank you all for your help! I really appreciate it. 



  • 2.  RE: How to Break Into the Reg Field

    Posted 13 days ago

    Hello Anon,

    Network - this can be done through local LGNs or Chapters, attending conferences, or getting involved in local events.  These are opportunities for people to get to know you, show your dedication, and also potentially find a mentor.  Applying for positions through job boards or agencies is almost akin to a lottery with some luck someone will review the resume and find something interesting.  There is none of the interaction at that point in time which may show your abilities and desire to work in regulatory affairs - plus applying through websites resumes are processed through algorithms that if the right keywords or information is not there - just will not make it even past the screening.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Principal Strategy Consultant
    NAMSA
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  • 3.  RE: How to Break Into the Reg Field

    Posted 12 days ago

    Hi Anon,

     

    I would only apply to a course that includes an internship with a company, it is the best way to get your foot in the door. In Canada, Health Canada takes part in these programs, perhaps FDA is involve in the US??

    Good luck!

     

    P

     

    Patricia R. Smith PhD RAC US

    Directrice Principale, Affaires réglementaires, Assurance qualité, Pharmacovigilance et Information médicale/ Senior Director, Regulatory Affairs, Quality Assurance, Pharmacovigilance and Medical Information

     

    Otsuka Canada Pharmaceutique

    2250, boul. Alfred-Nobel, bureau 301

    Saint-Laurent (Québec)

    H4S 2C9

     

    Bureau : 514-332-3057

    Cellulaire : 514-945-3996

    Télécopieur : 514-332-3107

     

     

     

     

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  • 4.  RE: How to Break Into the Reg Field

    This message was posted by a user wishing to remain anonymous
    Posted 13 days ago
    This message was posted by a user wishing to remain anonymous

    I wouldn't bother with a RA certificate at this stage, you are starting and this is an investment, in time and money, that I think is not surely warranty that you would get a job. It might give you an advantage, but nowadays employers prefer someone with practical experience rather than certificates but nowhere where this has been put to a test. Unfortunately the market is very tight and there aren't a lot of opportunities, so is a combination of skills and luck. When I got my first position in RA, right even before graduating from PhD school, it was because I was available right away to cover a maternity leave. That put me ahead of other candidates that had more experience, or had less availability. Is about those opportunities that you need to harvest and push for, particularly if they have some flexibility with remote working, because at your level I wouldn't expect you to be available on-site. You should, however, be mindful of how to enrich yourself from more experienced colleagues and learn key skills for your level, like listening, taking, and sharing notes during meetings. This is of great help for more senior professionals, because there's someone taking care of giving them the tools for accountability and do their job. Of course, don't just send your notes! Distribute them first to a few colleagues for feedback and to make sure you got all key decisions and topics. 

    Two extra things, I don't know where you are, but maybe this offer is still open? https://connect.raps.org/communities/community-home/digestviewer/viewthread?GroupId=97&MID=4967&CommunityKey=5af348a7-851e-4594-b467-d4d0983b6d89&hlmlt=VT

    And, if your university has a department to help researcher with their RA needs, try that. Duke has such an office, and also an online, free training program that could be your stepping stone. You'll be filling variations before you blink. 

    Best of luck colleague!




  • 5.  RE: How to Break Into the Reg Field

    Posted 13 days ago

    Hi Anon.

    You have received some great information and advice already from Richard and the second anonymous poster.  I will provide a couple of additional thoughts:

    1. As crazy as this sounds, don't limit yourself to breaking into the field in pharma or biotech or med devices or anything.  If you can get into a company in a regulatory role you will learn and develop many of the skills that will translate into these other areas of regulatory and at the same time obtain the "real world regulatory experience" that so many of the companies are looking for when you apply for something in their companies.  Also, it tends to be a bit easier to connect to a regulatory role in other layers of the industry like cosmetics, OTCs, food where the regulations are similar but where companies are a bit more willing to take a bit of a "risk" on someone with little or no specific regulatory experience.
    2. Regarding the masters program at Hopkins, I found it very useful but that was after I already had a few years of experience.  While you can get through the program with no experience or with ancillary experience it is in my opinion more valuable to have some basic understanding of the regulatory world before you start the program.  Also, just as a practical matter, many companies will offer educational support as part of their employee benefits package so you might be able to get some help in paying for the costs as opposed to having to manage the costs entirely on your own.
    3. RAC - my opinion - bad idea without some level of real world experience.  A portion of the testing is based on memorization of the regulations and the guidance documents from the specific area of the industry.  But there is another group of questions that are really more "practical" in their knowledge in terms of asking for the "best" answer when there are several "possible" answers to the question and some of them are also choices in the exam.  This is why the exam is recommended for those with 3-5 years of experience because you would have had the opportunity to hopefully actually experience some of these real world issues.

    I can only speak from my own experience but I think that you serve your career better and more fully by getting things in order to get yourself some real experience even in the form of internships or some other option to get yourself seen by the people in organizations that make hiring decisions for the regulatory positions.



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    Victor Mencarelli MS
    Global Director Regulatory Affairs
    New YorkNY
    United States
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  • 6.  RE: How to Break Into the Reg Field

    Posted 13 days ago

    Hello,

    If you want to get into regulatory affairs, I think it's a 2-point approach.

    Point 1 - NETWORKING/MENTEEING:

    I won't add any additional context to what Richard has stated around the importance of networking. This can be done in many ways, and he's laid out a few (Additionally, you could find a role at a medical device company that fits your current experience and then start networking within the company reg affairs department to build relationships. The advantage of this is you can start to cross train in the reg affairs department and get access to internal site systems to build proficiencies). The key here is building strong relationships within the industry.

    Point 2 - BUILD REGULATORY ACUMEN:

    This can be done in many ways, and depending on the experience you want to have could mean going, one direction or another here. The RAC exam is a good (relatively quick way) to show you have regulatory acumen. Some reg affairs jobs may even have it as a requirement or a recommendation.

    Other reg affairs jobs may have "advance degree preferred" which is where a regulatory masters comes in. Also, not all masters programs are alike. For instance, when I was at Northeastern getting my M.S. it was super writing intensive (e.g. we had many 10+ page papers, discussion board posts, quizzes, a whole class on how to use veeva vault, and we had to write a complete 'abbreviated' 510k). When I took classes at USC, it was almost zero work (with exception of a single group presentation at the end of each course) they would just bring in industry experts to talk each class (super informative). I'm currently taking courses at University of Florida and these are more collaborative on a weekly cadence (in class interactions, breakout sessions, ect).

    Other out of the box ways to show you have regulatory acumen:

    Write regulatory articles (for instance, write for the RAPS quarterly journal) pick a topic of interest and take a deep dive, and then submit your article to see if it gets picked up (e.g. I did one on Access Consortium). USC has a whole department that will help you craft whitepapers for reg affairs if you join their masters or reg affairs doctoral program. (But if you latch on to a mentor, they would probably do the same for you if you give them coauthor credit).

    You could also start a podcast or YouTube channel, talking about medical device regulatory affairs (reach out to people in the industry [here or on linkedin] that are further along the journey than you and invite them to speak on your channel) and have a conversation. [these continue point 1 above].

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

    Now, if it were me and I were starting from zero… I would start networking on RAPS, start drafting white papers for RAPS (these both cost you zero $) and then I would be applying for a medical device company I'd want to work for like Stryker in an area I already have experience (or an entry level technician type role). Once with company, I would start my internal networking, then RAC or Masters or both and have my company pay for it. 

    People will tell you a lot of this is about luck… But Luck is just when preparation meets opportunity. Be prepared so when the opportunity strikes, you're the "lucky" one. I call it "manufactured serendipity".



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    Andrew Nelson
    Senior Associate | Global CMC – Vaccines
    Pfizer Inc
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