Description: The purview of regulatory affairs is compliance. Professionals in regulatory affairs work in government or the private sector. The largest governmental agency employing scientists in the capacity of regulatory affairs is the Food and Drug Administration, for which the Center for Drug Evaluation and Research has the responsibility for evaluating new drugs before they can be sold, the Center for Devices and Radiological Health has the responsibility for regulating firms the manufacture medical devices, and the Office of Regulatory Affairs has the responsibility for oversight of medical products and inspections of facilities producing those products. Within the private sector, individuals in regulatory affairs advise on legal requirements (operational) and/or shape the regulatory environment (strategic), almost always in the capacity of interfacing optimally with governmental regulatory agencies. They can work with any number of different teams within a company, for example those dealing with clinical design, pre-market approvals, and adverse effect monitoring. Responsibilities include project delivery, dossier quality, and response to questions by regulatory agencies. The work is noted by all in the profession as quite detail-focused. It involves writing and reviewing documents that are not infrequently thousands of pages long. As one individual put it, “if you can’t manage tiny nuances of data in a multigigabyte document, you’re in trouble.” The job requires an understanding of basic and clinical science, and to some extent business, as well as government language and procedures.
Advantage of advanced degree: Formal training in science is essential for regulatory work. While scientists with BS, MS, PharmD, PhD, and MD degrees are all found in the profession, most agree that advanced degrees are essential for advancement to upper level positions. Advanced degrees can be essential, as well, in landing entry-level research positions within a company that in turn permit eventual transition to regulatory affairs, as many companies prefer to recruit from ‘within’. Advanced degrees are also noted to help with the technical aspects of the science and to provide greater degree of credibility in interactions with scientific colleagues and government agencies.
Key competencies: The most widely cited competency is attention to detail, but this presupposes a knowledge of the information that requires the detail. This is generally related to basic and clinical science, hence all areas of scientific pursuit are essential. The information required of the private sector also relates to government requirements, but the focus of scientific training on detail is conceded to benefit this as well. Highly cited, as well, are competencies relating to excellence in written and verbal communication and to teamwork.
On-campus student organizations: None.
First steps: The most practical step beyond evaluation of printed and web-based resources is, as almost always, contacting alumni who work in the field. There are no on-campus student organizations devoted regulatory affairs, however Penn’s Institute of Translational Medicine and Therapeutics (ITMAT) sponsors a Masters program in Regulatory Affairs and can therefore be a good source of information. Indeed, the growth of such programs has provided an increasingly important source of viable candidates for companies. Many recommend RAPS (Regulatory Affairs Professionals Society) as a source of information and of online courses and certificate programs.
- Regulatory Affairs Professionals Society
- David Jensen, Tooling Up: The Regulatory Affairs Career Track | Science Careers
- James Austin, Regulatory Affairs: Interview With a Contact Recruiter | Science Careers
- Katherine Poulin-Kerstien, Regulatory Affairs: A Lifetime of Learning | Science Careers
- FDA Center for Drug Evaluation and Research
- FDA Center for Devices and Radiological Health