How I Broke into Regulatory Affairs, and How You Can, too.

In my first post I explained how I came to work in regulatory affairs. When I meet students, attend conferences, or speak on panels, I am often asked about how others can pursue a career in regulatory affairs, too. Today I want to address that. As I mentioned in that initial post, this is a booming field with a plethora of opportunities. It's an exciting and meaningful business to be in and we will continue to see growth in the years ahead with all of the innovative technology out there. My very unofficial advice based on my own experience is as follows.

First, check out your local and not-so-local resources. The Regulatory Affairs Professional Society (RAPS) is a great place to start. They offer education and training, networking, career resources, and more. In their own words:

"The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, non-lobbying nonprofit organization. RAPS offers education and training, professional standards, publications, research, knowledge sharing, networking, career development opportunities and other valuable resources, including Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence."

They're headquartered in Rockville, MD but have worldwide offices and local chapters.

They have also compiled this very helpful list of regulatory affairs degree and certificate programs that are available nationally and internationally.

Lots of cities have awesome regulatory affairs networks that help professionals meet people, get involved, and break into the field (RAPS does this too). For instance, in San Diego the San Diego Regulatory Affairs Network (SDRAN) offers opportunities for networking and mentorship, as well as internship programs and classes. In fact, I am taking their course on Canadian regulatory this month! 

In their own words: "SDRAN is a nonprofit organization dedicated to educating and supporting our members through various educational and professional development venues including:

   • Monthly educational programs
   • RAC Study Groups to prepare for the US and EU exams are offered every summer
     and include a reimbursement option for those who are not eligible for a company
   • Mentoring program to help promote the career growth and development of our

UCSD Extension also offers classes and certificate programs.

Speaking of education, there are other ways you can get involved via education even if not directly enrolled in these programs. In my last year of grad school I started taking classes that had to do with things like patent law and the history of FDA, which gave me a taste for something outside research science. In addition, I expect opportunities to continue to grow with technology. For instance, universities seem to be starting to focus more on medical devices in innovative ways. In some cases, students shadow physicians to get a view into their world, then begin creating things based on the unmet needs of the hospital. Pretty exciting stuff.

So, local and national resources? Check.
Education? Check.
Next: how do you get a regulatory job if didn't cut your teeth at FDA? What else: Networking.

Roll up your sleeves. Talk to people. Tell people what you're interested in and offer to help where you can. There may be small ways to network and learn in your current role that you may be missing out on.

I'd always recommend getting a job in an industry you're interested in, and volunteering your services to the regulatory folks at your company. Maybe you're already in biotech or at a med device company doing R&D, or something similar. If there's a regulatory team at your company, chances are your paths will cross at some point, whether you're in marketing or in the lab: regulatory permeates everything, and the team will have to work across the organization to help with a submission. That means there's an opportunity to get involved, learn, offer to help, and either shift over to that department or, with the added help of the resources outlined above, maybe move on to something else.

A final note on networking: Just do it! You never know where a conversation will lead. When I was starting out on my own, I relied on students, professors, friends, and anyone I knew that could help me learn. From hiring a QuickBooks teacher, to throwing together a website, or knowing someone who knew someone who could help introduce me to a potential a client - I couldn't afford to be afraid to let people know what I was doing.

Have a question? Something I can help clarify? Let me know in the comments!