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Regulatory Affairs has developed from the desire of governments to protect public health by controlling the safety and efficacy of healthcare and related products. Regulatory affairs specialists work at the interface between business and government regulations. This career requires an understanding of science and business, as well as government language and procedures. The work is very detail-focused, as it involves writing and reviewing documents. Opportunities in this career path can be found in a variety of companies in the Biotech and Pharmaceutical industry, including medical devices, diagnostics, cosmetics, and nutritional products.

Example Job Titles

Regulatory Affairs Scientist | Regulatory Affairs Coordinator | Regulatory Affairs Specialist

Get Training & Experience

• Start to learn industry and regulatory terminology, acronyms, and documents
• Get additional advice on how you can prepare for this career from scientists who have recently transitioned into a role in this field, as well as from those who have made hiring decisions.
• Commissioner's Fellowship in Regulatory Affairs at the FDA (US Food & Drug Administration)

Additional Resources

Articles:

• The Regulatory Affairs Career Track

• Careers in Regulatory Science

• Fellowship: Regulatory Affairs Training Fellowship Program at the FDA

Books:

Alternative Careers in Science: Leaving the Ivory Tower

• (Chapter 12)
• Cynthia Robbins-Roth
• San Diego: Academic Press 1993

Career Opportunities in Biotechnology and Drug Development

• (Chapters 12-14)
• Toby Freedman
• Cold Spring Harbor, NY: Cold Spring Harbor Laboratory Press 2008

Professional Societies:

• Regulatory Affairs Professionals Society (RAPS)

• Drug Information Association (DIA)

• American Society for Quality (ASQ)

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