Career Options Series: Regulatory Affairs

April 13, 2016

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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Who’s Hiring Now? Check Out Regulatory Science

October 5, 2010

smiling peopleWhile news on the job market is still grim, there are a few areas that are growing in spite of the down economy – some of which have more jobs than viable candidates to fill them.

One such sector is regulatory science, a field that has been growing steadily for the past several years.

Regulatory science includes:

  • Regulatory affairs
  • Regulatory writing
  • Risk management
  • Compliance
  • Regulatory law

Regulatory scientists may work in any of these areas, evaluating potential products and trials, mediating among various parties, finding common ground, and gaining consensus.

According to the article All in the Details: Careers in Regulatory Science Exit Disclaimer on the Science Careers website, “The field [of regulatory science] requires expertise from scientists in a variety of disciplines, including physicists, life scientists, chemists, and engineers. FDA [U.S. Food and Drug Administration], a natural home for regulatory scientists, offers employment in more than 30 distinct disciplines, including research science, pharmacy, statistics, veterinary medicine, nursing, and clinical medicine.”

“Regulatory science is an area that usually has more jobs than qualified candidates,” the author goes on to say. “Some areas are falling far short of filling jobs…global regulatory affairs (particularly positions that require Spanish or Japanese language skills), biomarkers, and diagnostic testing [are] areas that are especially strapped for applicants.”

Skills necessary to be successful in this field include:

  • Project management
  • Organization
  • Negotiation
  • Communication
  • Ability to learn from the experience of others
  • Teamwork

The Regulatory Affairs Professional Society (RAPS) Exit Disclaimer website includes this list of skills and other relevant tips and information on entering the field. The RAPS 2010 Scope of Practice & Compensation Report for the Regulatory Profession is especially helpful, showing salary information by degree level, certification, type of employer, and more. For Ph.D.-level candidates, the salary for Associate positions start in the low $80K’s, while Manager-level positions move into the $120K range.

While there are jobs available, training is still required. There are graduate certificate and degree programs Exit Disclaimer in regulatory science, as well as a certification process. Regulatory Affairs Certification (RAC) Exit Disclaimer is a recognized credential sought by many employers.

Another point of entry to consider is a fellowship in regulatory affairs. The U.S. Food and Drug Administration, for example, offers the Commissioner’s Fellowship Program, a 2-year fellowship that combines coursework with the development of a regulatory science research project.

Before investing time and potentially money into training for this career, meet with regulatory professionals and find out all you can about their work, their own career paths, and the ins and outs of the profession. RAPS has several local chapters Exit Disclaimer, many of which have their own LinkedIn Exit Disclaimer groups. Check out a group in your area, or email the chair directly to set up a coffee or lunch meeting, or even a phone call.

The more you know, the better prepared you will be to step into this exciting career!