Joy Sharp is a former FDA Regulatory Counsel with more than 14 years of service at the U.S. Food and Drug Administration. She has advised C-suite and corporate clients on FDA regulatory strategy, compliance, and enforcement across drugs, biologics, foods, and emerging technologies, including responses to Form 483 observations and Warning Letters, CGMP compliance, labeling, promotional review, and Drug Supply Chain Security Act requirements. Joy regularly interfaces with FDA centers including CDER, CBER, and CFSAN, and provides strategic guidance to help companies align business objectives with evolving regulatory expectations.
During her tenure at FDA, Joy held senior roles within CDER, the Office of the Commissioner, and the Office of Regulatory Affairs, shaping policy on pharmaceutical quality, drug and biologics manufacturing, import safety, and national enforcement strategy. Her work included drafting agency policy, standardizing warning letter practices, responding to Congressional inquiries, and leading cross-agency initiatives impacting drug quality and food safety.
Joy holds a J.D. from the University of Maryland School of Law.