Rebecca Frey-Cooper CDER/OMQ/US FDA

Rebecca Frey-Cooper is the Associate Director for Regulatory Programs in the FDA Center for Drug Evaluation and Research (CDER), Office of Compliance, Office of Manufacturing Quality. In this role she provides oversight and direction for the  review of drug manufacturing quality issues, regulatory action recommendations regarding inspections, and development and implementation of compliance policies. Rebecca Frey-Cooper received her undergraduate degree from King’s College in 2005 and worked as a laboratory assistant at a nitroglycerine API manufacturer.  She obtained her PhD from the University of South Carolina in analytical and organic chemistry techniques focusing on chemical processes that govern the natural attenuation of microbial signals.  She subsequently worked for the API manufacturer, Noramco (a Johnson & Johnson subsidiary), as a post-doctoral fellow and senior scientist within the laboratory and production with emphasis in method validation, technical transfers, and new product introduction. In 2013, she joined the FDA and has served in various functions within CDER’s Office of Compliance. She is currently overseeing regulatory and enforcement programs for both foreign and domestic Current Good Manufacturing Practice (CGMP) cases.