Regulatory Open Forum

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  • 1.  Additional Education

    This message was posted by a user wishing to remain anonymous
    Posted 24-Jan-2023 09:26
    This message was posted by a user wishing to remain anonymous

    Good morning!

    Besides obtaining RAC, PMP, or CAPM, what additional higher education (masters, certifications, etc) would you recommend to an associate looking to further grow in the profession?

  • 2.  RE: Additional Education

    Posted 25-Jan-2023 10:28

    It really depends on what focus want to take such as pharmaceutical, medical devices, biologics, or something else.  Then within the industry could be regulatory, regulatory compliance, quality assurance, quality engineering, etc.  If staying purely in regulatory such as submissions, there not necessarily additional certifications (though could do a Masters programme), but there would be training in specific areas such as NDA development, clinical trial management, or 510(k) submissions.  If want to stay more in regulatory compliance or quality assurance, then areas like auditing certification or compliance training courses would be helpful.

    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs

  • 3.  RE: Additional Education

    Posted 25-Jan-2023 10:44
    Hi Anon.

    I am always a believer in learning anything and everything you can.  Find what interests you and really deep dive into it.  Any opportunity to learn in this profession is gold for your future growth and future versatility.  I personally have my MS in Regulatory Science but more importantly I have always been willing to take on any new challenge or learning opportunity as I have developed.  Some of the things you learn for these "unexpected" or less "academic" or "certified" pursuits can be the true stepping stones for your next career move or progression.  Remember as you grow in your career it becomes more about experience and less about academic work (at least that is what I have noticed).

    Victor Mencarelli MS
    Global Director Regulatory Affairs
    New YorkNY
    United States

  • 4.  RE: Additional Education

    Posted 26-Jan-2023 01:11

    I have been in the industry going on 23 years. In that time, the only thing I have found important is investing in yourself, your experiences, your education, and opportunities to grow.  Many of us have similar credentials; I graduated with my MBA this past May. Why was that important; I found that aside from the technical expertise, I needed to round my business acumen. As one other said in this thread, you need to think about your short and long goals and your vision for yourself in 10 or 20 years. Also, what makes you want to get up in the morning to conquer the day's challenges and make an impact?

    I close with this; even after my tenure in the industry, the last vision I have for myself is a Ph.D. Note it's not just a vision but putting the steps toward the execution.  Just remember to invest in yourself continually!

    James W. Monroe, MBA, MS, RAC, CQA
    President & CEO, Head of Regulatory Affairs
    Global RQC Med Device Solutions, LLC.
    Somerset, NJ