Rebecca (Becky) Devine, PhD is an independent regulatory consultant with over 30 years of experience in the regulation of biological products. She began consulting in 1999 after leaving the U.S. Food and Drug Administration (FDA). She joined the FDA in 1979 as a Microbiologist, and held various positions in the Center for Biologics Evaluation and Research (CBER) throughout her 20-year FDA career. Throughout her CBER tenure and recent consulting career, she has been involved in the review of license applications, inspections, and chemistry, manufacturing and controls of vaccine, therapeutic, and biotechnology derived biological products. Dr. Devine earned her BS and PhD degrees in microbiology from the University of Maryland. She is currently an active member of the Parenteral Drug Association (PDA) serving as Immediate Past Chair of the Board of Directors.