Kimberly E. Rains, PharmD FDA

Kimberly Rains, Pharm.D. serves as a Captain in the United States Public Health Service Commissioned Corps (USPHS) and at the Food and Drug Administration. CAPT Rains received her Bachelor of Science in Chemistry from North Carolina Agricultural and Technical State University. She worked as a chemist for three years in the pharmaceutical industry before moving to the Washington, DC Metropolitan area to attend Pharmacy School at Howard University.  She was awarded a Doctorate in Pharmacy in 2001. She completed a Managed Care Practice Residency and began a career at a Managed Care Organization serving in many supervisory roles.  She transitioned into the USPHS in 2008 into a newly created position in the Office of Biotechnology Products (OBP) as a biological product labeling reviewer.  She was responsible for creating collaborations and pathways to review labeling. She then transitioned to the Office of Generic Drugs to master generic drug labeling.  In 2015, she transitioned back to OBP in a newly created role as the Associate Director for Regulatory Affairs.  In this role she collaborates within the agency on projects to identify and mitigate process gaps.She works closely with the Director and advises him on regulatory issues related to biological and biosimilar products.