Susan E. Polifko
PharmD, RAC-US, USFDA- FDA/CDER/OPQ/OPMA
CDR Susan E. Polifko has more than 18 years of experience with the FDA. In 2022, she was appointed as the Associate Director of Regulatory Affairs (ADRA), Office of Pharmaceutical Manufacturing Assessment (OPMA). Prior to joining OPMA, she has been with OPQ/Office of Program and Regulatory Operations (OPRO) as an RBPM in OPRO’s Immediate Office, Business Operations staff. She served as lead project manager for Pre-approval inspection management, quality-related activities for enforcement actions, and facility-related industry meetings. She served as project manager for OPQ’s response to the COVID-19 public health emergency and the International Coalition of Medicines Regulatory Authorities collaborative assessment and hybrid inspection pilots. Prior to joining OPQ in 2016, CDR Polifko earned her PharmD in 2005 from Wilkes University Nesbitt School of Pharmacy, Wilkes Barre, Pennsylvania. She started her regulatory career in the Office of Generic Drugs (OGD) as a Regulatory Management Officer with the Regulatory Support Branch (now known as Division of Filing Review (DFR)) in July of 2005. She moved to Office of Regulatory Affairs, FDA, in Harrisburg, Pennsylvania as an Investigator in 2008. She returned to OGD in 2013 as a filing reviewer and was promoted to Project Manager Team Lead/Special Assistant to the Director of DFR.