Regulatory Open Forum

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  • 1.  RAC Certification and Master's program

    Posted 28-Dec-2011 13:10
    Hello to all,
    I have been doing research on RAC certification and getting a Masters in Regulatory and I need a little advice.  Is it better to be RAC certified, obtain a Masters in Regulatory, or get both?  I have been in the field of Regulatory about 4 years and I wanted to know what would be the best route to take to advance in my career.  Thanks for all feedback.

    Kind regards,

    -------------------------------------------
    Tracie Waters
    Regulatory Document Specialist
    TX
    United States
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  • 2.  RE:RAC Certification and Master's program

    Posted 29-Dec-2011 17:19

    Tracie,

    I would recommend both. A Master's degree indicates a great deal, but having the certification also indicates meeting certain recognized standards.

    Hope this helps,
    Steve

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    Steven Ziemba
    Albany GA
    United States
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  • 3.  RE:RAC Certification and Master's program

    Posted 30-Dec-2011 16:44
    Hi Tracie,

    I'll try to give you a bit more background info than Steven, for you to evaluate the strength of my opinion on the value of RAC Certification and an RA Master's Degree.  My opinion on this matter is evidence-based and developed over the 6 years I have been working in Regulatory Affairs in the San Francisco Bay Area, but, as all opinions, it's relative to my particular career path and the US region where I work.

    My RA Certificate from San Diego State Univ. (four 11-week online courses) coupled with my periodic follow-up for one year of an RA Director @ a start-up company landed my first RA job in pharmaceuticals.  I have an additional 8 years experience in the biomedical industry in R&D, QA-Validation and Sales.  At first, the RA job was a temporary P/T contract, but it turned into a F/T position after 6 months because the company was expanding its pipeline.  While working there as a Senior RA Rep, I got the RAPS RAC Certification in 2007.

    When I sensed that my company was about to lay-off the employees they no longer needed, due to a recent merger, I started applying fo rthe RA Masters with SDSU, since I could transfer my RA Certificate towards the MS Degree.

    When I was "in-transition" and getting unemployment for almost a year, the RA Masters Program served as a time-filler to keep me connected to the industry, besides the many local conferences I attended.  I interviewed for both device and drug companies only in the SF Bay Area for a period of 2 years with an average of one interview (phone or face-to-face) per month with small, medium and large companies.  From these interviews, it became crystal clear to me that my involvement in an RA Masters Program had absolutely no bearing on how the employeer evaluated me! 

    It was eye-opening to realize that hiring in RA is ALL about How much Specific Work Experience you have on a Specific product in a Specific therapeutic area with a Specific FDA Center!!  Employers prefer not to have to do much training (there's no time and it's too much work!!), and they'll will always choose Experience OVER Academics.  Eventually, I got a temporary contract position with an IVD-Device company, which led me to obtain my current F/T direct hire position with Celera, another IVD company.

    At all my RA jobs, I discovered that I was better at writing than most RA Reps, and that I learned product-specific RA Strategy/Regulations very fast because of the RA Master's courses I had been taking.  Although I felt some SDSU courses were a waste of my time & money because the teachers were not very responsive, the materials were not updated and the course content was not challenging enough, I still got some value out of every class.  I have 2 more courses to take and will get the RA Masters Degree by end of 2012.

    I probably would have chosen the RA Masters at either John's Hopkins or Northeastern Univ., after comparing courses that some workmates were taking, even if they were a little more expensive.  Those universities' RA Masters Programs are much more well-organized, updated and demand more of their instructors to deliver high learning-value in every course.  But I had already invested in SDSU, and at the end of the day, the value of an RA Masters ends-up translating into higher credibility for the MS credentials after your name.

    In the long-term, once you accumulate that valuable & irreplaceable RA Work Experience, the MS and RAC after your name do signal that you are an RA Professional to employers.  Getting that first RA experience is as unpredictable and varied as there are people, employers and regional economies.  There's absolutely NO Formula and NO prescribed pathway to advance one's RA career!

    Another Career Rule I observed directly from 10 RA/QA professionals and indirectly through many people is that - to get promoted in RA/QA in the Biomedical Industry, you have to leave your company.  Corporate policy is rigged against individual promotion because that's how they save money on salaries!  I know of 5 people who finally returned to their original company with a higher RA title (Sr. Manager or Director), only after first leaving for another company for a higher title, and then applying back, when the higher title became availbale at their original company. 

    Career Advancement is like a Chess-Game - you have to predict the opponent's next 3 moves, and be a step ahead.  It's not for people who like to sit comfortably and wait for a nice job to fall from the sky!

    Best of Luck to you and keep applying to RA jobs, as I do;  you need to work the numbers and be willing to do a few lateral moves, if needed.  Also, the more you learn how to Critical Think in RA, the more valuable you become to companies, and this will transpire in job interviews.

    Regards,
    Ana

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    Ana Moura, RAC
    Sr. Specialist, RA
    Celera Corporation (a Division of Quest Diagnostics)
    Alameda, CA, United States
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  • 4.  RE:RAC Certification and Master's program

    Posted 03-Jan-2012 08:39

    That is a good perspective Ana. I have 20+ years in QA and regulatory and am focusing more on Regulatory recently. I enjoyed reading about your experience.

    Thank you.
    -------------------------------------------
    Lenisse Lippert
    Ambiopharm, Inc.
    Beech Island SC
    United States
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  • 5.  RE:RAC Certification and Master's program

    Posted 04-Jan-2012 10:37
    I regularly get requests from colleagues - both internal and external - regarding the benefits of the RAC designation and thus, while a bit biased, wrote an article for November's issue of Focus that might prove helpful to the discussion thread.  (See

    Why Do I Need Regulatory Affairs Certification (RAC)?, RAPS Focus.  Vol. 16, No. 11, November, pp41-42 and 43).

    I also appreciated Ana's candidness and frank comments below.

    Regards,

    Ray
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    Raymond Huml
    Executive Director, Global Due Diligence
    Durham NC
    United States
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  • 6.  RE:RAC Certification and Master's program

    Posted 03-Jan-2012 09:33
    I want to quibble with Ana's statement about career advancement. Sometimes it indeed is true. However, not always. For instance, I started at AMS as a Regulatory Specialist and ended up (so far) in my current position as VP, Quality and Regulatory 15 years later. Of course, along the way, I made a point of taking advancement opportunities in R&D, project management, clinical affairs and quality as well as regulatory. There is obviously a timing concern - does your company have the right opportunity to move at the time you are ready for it? If not, then it can be necessary to change companies. However, most higher level management positions in RA are also looking for leadership experience in other, related areas - particularly at smaller to mid-sized companies - and RA professionals should be aware when those opportunities occur. Larger companies, on the other hand, often have internal employee development program specifically intended to develop both regulatory management and the regulatory "technical" track.

    One of the harder problems in management occurs when you know someone with high potential isn't quite ready for that next level, but you are pretty sure they can get the title at another company? What do you do? Risk setting them up to fail? Lower your standards? or risk losing a valuable employee? There are no good answers in this situation. It usually, however, has nothing to do with salary.

    I think we all need to be careful as Regulatory Professionals not to be jaded about our employers, the FDA or others. I've been in too many regulatory meetings where everyone wants to complain about something and it certainly doesn't serve us well as a profession.


    -------------------------------------------
    Ginger Glaser M.S., RAC
    Vice-President, Quality and Regulatory Affairs
    American Medical Systems Inc
    Minnetonka MN
    United States
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  • 7.  RE:RAC Certification and Master's program

    Posted 03-Jan-2012 10:57

    First off I would like to say Happy New Year's to everyone.  I truly thank you all for your input.  After reading all of the responses I can say that I have reached a decision.  I am thankful for all info and it has really been an eye opener from several perspectives.

    Kind regards,

    Tracie
    -------------------------------------------
    Tracie Waters
    Regulatory Document Specialist
    TX
    United States
    -------------------------------------------








  • 8.  RE:RAC Certification and Master's program

    Posted 31-Dec-2011 23:30
    Hello Tracie,

    My own findings agrees with Ana.  As a scientist, I am transitioning to the RA field.  I was faced with a tough choice, should I pursue a Masters course or do the dual certificate courses offered by the RAPS.  I am planning on the certificates.  My reasons, well I have spoken with various consultants, directors at pharma. companies,  and hiring managers.  The advice I was given was to try and get some experience in the RA field and work your way up.  You should consider taking the certificate, and because you have RA experience, you'll have the opportunity to take the certification exam and have the RAC after your name.

    The "Academic" route i.e the MSc course , really doesn't carry much weight from my own research and talking to various professional .

    I'm planning to take the certificate program offered by the RAPS online university (a 12 months program). Another advantage to the certificate program, it costs a fraction of the MSc course.

    I have just started a temp. position in RA, so I hope this is a stepping stone for me towards a career in RA. I hope this helps.  Good luck.

    Upendra

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    Upendra Topiwala, Phd
    North Haledon NJ
    United States
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  • 9.  RE:RAC Certification and Master's program

    Posted 03-Jan-2012 12:51
    Tracie -

    My reaction to your inquiry was, do you already have a technical master's degree?  If you already have an MS in engineering, biology, chemistry, or law, you definitely do not need an MS Regulatory Affairs.  If you don't have a master's degree, but have extensive work experience such as in another function within a medical device / pharma company, such as Production Supervision, QA, or Marketing, then the need is optional.  If you have neither an MS nor work experience, you may find that the MS program provides excellent "compressed experience" and will help you in your interviews, your cover letters, and your work.  Until you have finished the program, it probably will not help you in getting interviews.

    The previous reply mentioned the community people like yourself within the MS program.  This is a very valuable aspect of the program and one that you don't get to the same extent if you are taking all your courses on-line, such as with the certification programs she mentioned.  

    Finally, take a leadership position within your local RAPS organization.  As a hiring manager, I definitely respect participation and I do meet people at these events.

    I believe in education, but not to the extent that you develop significant personal debt.  If you can work and study at the same time, that is ideal.

    Best wishes for success,

    Kate

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    Katharine Stohlman
    VP Regulatory Affairs & COO
    Thermedical
    Somerville MA
    United States
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  • 10.  RE:RAC Certification and Master's program

    Posted 03-Jan-2012 11:48
    Tracie:

    My recommendation is both.  Scanning potential employees, both certification and the degree would hold parallel credibility from my perspective.

    Peter

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    Peter Takes PhD, RAC, FRAPS
    Senior Director, Clinical & Healthcare Compliance & Clinical Compliance Officer
    Stereotaxis Inc
    St Louis MO
    United States
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