Regulatory Affairs Brings Science Human Relevance

Career Story by Joan Adamo, Assistant Professor and Director for Regulatory Support Services

Question: What is a good career if you love science, have an eye for critical review, appreciate the need to follow the rules and secretly have a desire to wield some modicum of authority?

Answer: Regulatory Affairs!   (aka. the federal regulation of drugs, biologics and medical devices)

My career trajectory was constantly being nudged by personal involvements; however, I did not let that deter me from finding a job that piqued my interest and allowed me to expand my horizons into the directions I wanted it to turn.

After an exciting five years of living in Manhattan for graduate school, paired with a slightly less exciting five years of watching yeast grow, I knew that I was ready to tackle some research questions that were more human focused.  This led me to apply for infectious-disease postdoctoral positions.  The switch from polarized exocytosis in yeast to virology research, where I studied terminal repeats in human cytomegalovirus, gave my research and knowledge of the literature a heavy dose of human relevance. 

When my personal life intercepted, I happily curtailed my postdoctoral position at just about two and a half years of work and set my sights on Washington, DC. I did not think that I was cutting the postdoctoral position too short because my project was reaching a logical concluding stage and a first author publication was in the late-stages of editing.  Since life had dictated my new location, I focused on where I could find an intellectually stimulating position, and as before, I was still looking to move closer to human relevance with my work.

After searching through the college and university labs, small companies and government openings in the DC area, I found a posted research position at the US Food and Drug Administration (FDA).  The work seemed VERY relevant to humans, and as I looked into it further, I was intrigued to see that the Agency did both basic research and regulatory work (among other things).  The Division of Viral Products (DVP) in the Office of Vaccine Research and Review focused on the research and review of viral vaccines, and this turned out to be a perfect match for me!  While I came in as a research fellow, my interest in regulatory processes soon afforded me the opportunity to conduct reviews of new products that companies and Sponsor-Investigators were hoping to test in humans.  I spent about five years in DVP (across two different labs and changing to a Staff Fellow when the Agency was hit with a public health need) and loved the work that I did there.  It gave me opportunities to learn how drugs (vaccines specifically, but generically drugs and biologics all around) are regulated, categorized, approved, recalled, listed and inspected.  There were many opportunities for trainings and self-improvement. 

As my family was growing larger and grandparents needed more attention, this time the transition was back to Rochester, NY.  Luckily, I was able to apply my regulatory affairs skills at the University of Rochester where the new Clinical and Translational Science Institute (CTSI) was just getting off the ground.  Join me Wednesday January 10 (10:00 – 11:00) in the  Northeastern Conference Room (1-9525) to learn more about my career decisions, what it was like working at the FDA and the projects that take place at the CTSI’s Office of Regulatory Support.

Tracey Baas | 12/11/2017