Regulatory Affairs

The goal of regulatory affairs is to protect the public health. Potential employers include the government, the pharmaceutical industry, small biotech companies, contract research organizations, consulting firms, or non-profits. You could work on small molecules, biologics, or devices: submitting or reviewing new drug applications; designing or reviewing preclinical protocols, clinical trials, manufacturing, or post-marketing processes. You could also be involved with compliance issues (inspections and possible product recalls).

A regulatory affairs professional works closely with stakeholders inside and outside his/her organization. Therefore, excellent verbal and written communication skills are essential. Additionally, as regulatory standards evolve and priorities change, one needs to stay up-to-date, and be able to adapt. Some roles may involve a lot of travel.

• Videocast by NIH OITE: Careers in Regulatory Affairs.
• Chapter 12 in “Career Opportunities in Biotechnology and Drug Development” by Toby Freedman.
• Regulatory Career Advancement Guide by RAPS. This guide includes information on transitioning to the profession
• Related blogs, such as Barry Friedman’s blog
• Follow the discussion and other resources at the Food and Drug Law Institute website.
• Attend the FDA Virtual Hiring Event.

• Courses to consider:
  • Drugs, Medical Devices, and Government
  • Food and Drug Law (KSAS-AAP)
  • International Regulatory Affairs (KSAS-AAP)
  • Technical Writing in a Regulated Environment (KSAS-AAP)

  Check our list of courses for more.

• The American College of Toxicology offers an annual course: Toxicology for Industrial and Regulatory Scientists.
• Learn about the work done at the FDA through the FDAVoice blog post.
• FDANews provides webinars and newsletters to keep up with the latest developments in the field.
• Learn how to obtain a Regulatory Affairs Certification.
• In preparation for a job in regulatory affairs, consider working for a Contract Research Organization (CRO) for one or two years, so that you gain experience in different aspects of the field.

• NCI/FDA Interagency Oncology Task Force (IOTF) Fellowship
• The Commissioner’s Fellowship program at the FDA
• Other fellowships and internships at the FDA
• Biogen Idec: Regulatory Affairs - (CMC)/Manufacturing Sciences Fellowship
• Windows to Regulatory Research Internship Program with the FDA Center for Veterinary Medicine.

• Join the regulatory affairs professional society (RAPS) and attend their events.
• LinkedIn group of RAPS or other LinkedIn regulatory forums.
• Request informational interviews with Regulatory Affairs professionals at organizations that interest you.

• CASSS: a non-profit scientific society facilitating the interaction among industry, academic and regulatory professionals.
• Parenteral Drug Association
• American College of Toxicology
• RAPS: The Regulatory Convergence
• International Alliance for Biological Standardization (IABS)

LT. Leslie A. Rivera Rosado, Ph.D.
Senior Regulatory Scientist Officer, Food and Drug Administration
“As a Commissioned Officer of the U.S. Public Health Service and a Product Quality Reviewer at the FDA’s Office of Biotechnology Products, my mission is to ensure the health of the American people through a rigorous assessment of the quality, safety, and efficacy of biological drug products. I review, evaluate, and recommend regulatory actions on Investigational New Drug Applications (IND), Biological Licensing Applications (BLA), as well as biologic-medical device combination products. I also participate in the inspection of manufacturing facilities for compliance with applicable standards. As a regulatory scientist, I am also involved in the development of policies, guidances, and procedures in keeping with the provisions of the Public Health Service (PHS) Act and the Food, Drug, and Cosmetics (FD&C) Act.

If you are interested in a career in Regulatory Science/Affairs, in addition to a strong scientific background, I believe that it is essential that you possess critical thinking and analytical skills. When reviewing regulatory documents you need to be able to (1) ensure that they comply with applicable laws and regulations, (2) identify potential issues that might impact product quality, safety, and efficacy, (3) make scientifically sound risk-based assessments, and recommend regulatory actions. In addition, it is important that you work well as part of a team because when reviewing a regulatory submission, you will be working together with a multidisciplinary team that will determine the final regulatory action. You will also be in contact with the Sponsor (or applicant), providing feedback and guidance related to their drug development program and the review of their application. Therefore, good written and verbal communication skills as well as negotiation skills are indispensable to your success as a regulatory scientist. As a regulatory reviewer, you will also be working on various projects simultaneously, often under tight deadlines, thus, project management and time management skills are key in order to be successful.

In closing, a career in Regulatory Science/Affairs lies at the intersection of science, laws/regulations, policy, and public health, making it an exciting and rewarding career.”