November Feature: Scientists in Regulatory Affairs

November 07, 2003

Robin Arnette

Have you ever considered what the world would be like without pharmaceutical drugs? Or clean drinking water? Or food from the supermarket that is safe to eat? Millions of Americans depend on products and services for their health and well-being everyday such as over-the-counter drugs that treat everything from common colds to rashes. These almost indispensable products would not be available if it weren't for the valuable information provided by regulatory affairs (RA) professionals in government and industry.

While the Food and Drug Administration (FDA), for example, is responsible for making sure that each pharmaceutical product offered to the consumer is safe and effective, it must rely on RA professionals who specialize in the complicated drug approval rules. Other agencies such as the U.S. Department of Agriculture, the Environmental Protection Agency, the Occupational Safety and Health Administration, and the Drug Enforcement Administration also rely on RA for expertise. RA professionals not only keep up with American regulatory standards, they have to be just as proficient in drug development rules in other countries.

RA professionals come from a variety of disciplines such as law, academic and industrial research, and medicine. RA is a promising field for scientists searching for alternative careers because it offers a multitude of starting jobs and opportunities for advancement. Check out this month's spotlight on the world of RA.

		When Odds Turn Even [1] Meenakshi Garg describes the long and winding road that stretches from research to parenting, running a home business, and a career in regulatory affairs
		Science, Ethics, People and Law [2] Careers in regulatory affairs aren't limited to industry and government, as described by Jenny Dimond of the UK's Human Fertilisation and Embryology Authority (HFEA).
		A Talk with a Regulatory Affairs Recruiter [3] Science talent expert Joe Tringali talks about what it takes for a scientist to enter the world of regulatory affairs, and the outlook for future employment in this field.
		Making the Grade [4] Katherine Poulin-Kerstien profiles two high achievers who agree that formal training in science is essential for a career in regulatory affairs, but formal training in regulatory issues, is not.
		The Regulatory World - A Postdoc's View [5] Yatika Kohli, a Canadian regulatory affairs specialist, describes her career transition from a Ph.D. research scientist and notes the important decisions she had to make along the way.
		Open Standards in Science, an Answer to Regulatory Questions [6] Voluntary consensus standards, like those developed under the American National Standards Institute, provide an alternative for some industries to government regulations.
		Europe Whittles Down Plans for Massive Chemical Testing Program [7] The European Commission has scaled back proposed legislation on safety testing of commercial chemicals, yet it still represents one of the most ambitious toxicological programs ever undertaken. [Repost from Science News]
		The State of Affairs: An Overview of the Regulatory Affairs Profession [8] Sherry Keramidas, executive director of the Regulatory Affairs Professionals Society, provides an overview of the state of the field.
		SDSU's Approach to Training Regulatory Affairs Professionals [9] Larry Gundersen describes San Diego State University's program that teaches not only the basics of regulatory requirements, but also how FDA interprets and enforces its regulations.
		Scientists in Regulatory Affairs Resource Page [10] The resource page is a great place to begin your search on careers in regulatory affairs. Check out the regulatory affairs resources featuring organizations, societies, and institutes.

Links:
[1] http://sciencecareers.sciencemag.org/career_development/previous_issues/articles/2870/when_odds_turn_even
[2] http://sciencecareers.sciencemag.org/career_development/previous_issues/articles/2730/bringing_together_science_ethics_people_and_law
[3] http://sciencecareers.sciencemag.org/career_development/previous_issues/articles/2730/regulatory_affairs_interview_with_a_contract_recruiter
[4] http://sciencecareers.sciencemag.org/career_development/previous_issues/articles/2730/regulatory_affairs_a_lifetime_of_learning
[5] http://sciencecareers.sciencemag.org/career_development/previous_issues/articles/2730/from_research_to_regulatory_affairs_long_journey_to_a_complete_life_cycle
[6] http://sciencecareers.sciencemag.org/career_development/previous_issues/articles/2660/open_standards_in_science_an_answer_to_regulatory_questions
[7] http://sciencecareers.sciencemag.org/career_development/previous_issues/articles/2730/europe_whittles_down_plans_for_massive_chemical_testing_program
[8] http://sciencecareers.sciencemag.org/career_development/previous_issues/articles/2660/the_state_of_affairs_an_overview_of_the_regulatory_affairs_profession
[9] http://sciencecareers.sciencemag.org/career_development/previous_issues/articles/2660/san_diego_state_university_s_approach_to_training_regulatory_affairs_professionals
[10] http://sciencecareers.sciencemag.org/career_development/previous_issues/articles/2730/regulatory_affairs_resources