Career Options Series: Regulatory Affairs

OITE’s Career Options Series will give you a snapshot overview of different career paths. The goal of this series is to help you explore a variety of different options by connecting you to new resources.  A large part of making a good career decision is done by gathering information about that field.  We encourage you to follow up this online research by conducting informational interviews with individuals in each field. Search the NIH Alumni Database to find alums doing similar work.


What is Regulatory Affairs?Image of the words "Regulatory Affairs" with two figures holding a puzzle piece
A profession that functions to apply laws, regulations, and policies to the development, production, and sale of products within regulated industries, such as: food, pharmaceuticals, medical devices, energy, biotech, clinical, and health care products. Why is it needed? To make sure company businesses/products abide by applicable regulations, laws, and guidelines in every country where a product will be marketed.

Regulatory affairs requires expertise from multiple disciplines, such as: research science, physicists, life scientists, chemists, engineers, pharmacy, statistics, veterinary medicine, nursing, clinical medicine, etc.

Sample Job Titles
Regulatory Affairs Specialist, Regulatory and Quality Affairs Analyst,  Policy Manger, Scientist, Regulatory Affairs Associate, etc.

Sample Work Settings/Employers
Regulatory Affairs in the Federal Government:|
FDA
– FDA scientists review test results submitted by sponsors, so that the FDA can decide whether the drug is safe enough for clinical trials, whether the drug can be sold to the public, and what should go on the drug’s professional labeling.
USDA – Inspect food safety, and collect and analyze surveillance data of foodborne outbreak; conduct studies such as evaluations, like Child Nutrition Studies or Food Security Studies in response to the needs of policy makers and managers.
EPA –  Assess exposure, hazard and risk of chemical substances and/or toxic substances; assess risk of environmental pollutants, and develop biological indicators.

Regulatory Affairs in the Private Sector:
Industry – Gather data necessary for submission to government. Manage process of regulatory approval

Consulting/Regulatory Affairs Services – Provide evaluation of the best regulatory path. May provide outsources submissions and follow-up services.

Key Skills
– RA needs individuals with backgrounds in biology, chemistry, engineering, information technology, pharmacology, quality, toxicology, clinical sciences, writing and management
– Knowledge of science, regulations, and policy
– Verbal  and written communication skills
– Analytical and organizational skills, including the ability to evaluate potential product candidates and trials
– Project and time management skills
– Computer skills
– People skills, including the ability to mediate and find common ground among interested parties (research, production, sales, marketing, regulatory agencies, etc.) and gain consensus

How to get started
• Commissioner’s Fellowship Program (FDA)
• CDER Academic Collaboration Program (FDA)
• CATO Fellowship
• Trainings:
– The Regulatory Affairs Professional Society (RAPS) Online University
– NIH FAES Graduate School Classes (Look at current availability but previous relevant classes have     included Inside and Outside the FDA or FDA Regulation, Industry and Hidden IP)
– Master’s of Science in Regulatory Affairs programs
• Regulatory Affairs Branch (RAB), NIH, NCI

Professional Organizations
The Regulatory Affairs Professional Society (RAPS)
The Organization for Professional in Regulatory Affairs (TOPRA)
The Canadian Association of Professional Regulatory Affairs (CAPRA)

Additional Resources
OITE’s How To Series: Regulatory Affairs, including an archived video, slides, and more resources!

 

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Coming up in the Career Options Series, we want to know what you which work path you would like to see highlighted. Take a moment to vote below:

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