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Any information on a career in regulatory affairs?

I am interested in knowing if it is an easy field to break into once I get my masters. Also, is it a rewarding career financially? Are there online programs available? If you are taking the program or have taken it, is it a challenging field?

1 Answer

  • 1 decade ago
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    A MS in a technical field regarding the following regulated industries may/may not make it easy to get into RA-

    * Pharmaceuticals

    * Medical Devices

    * In Vitro Diagnostics

    * Biologics and Biotechnology

    * Nutritional Products

    * Veterinary Products

    * Cosmetics

    Regulatory professionals are responsible for guiding these healthcare products through the approval process and onto the market. Or you might work in other regulated industries, such as transportation or utility. The Regulatory Affairs Professionals Society (RAPS) site is deep with content on RA.(1) Online courses, certificates, and degrees are offered.

    (Yahoo! search found 7,760,000 pages about regulatory affairs schools, so there are many paths to take, Sara.

    Another deep site is FDA's Office of Regulatory Affairs(2), which has a navigator bar across the top for links to the above catagories. Typical examples of RA work are in "Development & Approval Process (Biologics)" and "Guidance, Compliance & Regulatory Information (Biologics)" sections in Vaccines, Blood & Biologics(3).

    The "golden rule" for Regulatory Affairs is "If it hasn't been documented, it wasn't done." (Failure to document something could lead to shutting down a business.)

    I was involved in RA for five years; the work is dead-line driven., which can mean 14-hour and more workdays to complete a product submission package. The pay is good, but the position often is not seen by others as a "professional" one, such as an engineer or scientist or sales person. Often a RA specialist is a "cost center," not a "profit center," and may be more vulnerable to being laid-off (unlike the three previously mentioned).

    As they say- "do your homework" and you'll learn if RA is what you'd like to do.

    Best success!

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