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Sonday L. Kelly, MS, RAC, PMP

Director
Division of Regulatory Operations and Programs / Office of Regulatory Operations / Center for Biologics Evaluation and Research / Food and Drug Administration

Sonday L. Kelly, MS, RAC, PMP, a proud public servant since 2010, is the Director of the Division of Regulatory Operations and Programs (DROP), in the Office of Regulatory Operations (ORO), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA). She provides oversight, strategic direction, and coordination of cross-cutting regulatory business operations and program projects for the Center. She oversees the Center's regulatory review processes and procedures, and regulatory staff training for biologics, devices, drugs, and combination products; implementation and interpretation of regulatory statues related to regulatory review; user fee billing, verification, tracking, and progress reporting. She has held various roles in CBER's Office of Blood Research and Review (OBRR) as Staff Director, Team Lead, and Regulatory Project Manager. She is an expert in regulatory review and project management of meetings with industry, INDs, IDEs, ANDAs, NDAs, 510(k)s, PMAs, and BLAs. She enjoys mentoring staff throughout the Agency.

Before joining FDA/CBER, Sonday worked for 7 years in process development at the American Red Cross and ProMetic Biotherapeutics, purifying therapeutic proteins from human plasma. She worked for 3 years at Wyeth Vaccines manufacturing the injectable influenza vaccine, and as a Manufacturing Supervisor overseeing the sterile filtration process of phase 3 clinical trial materials for the nasal spray influenza vaccine.

Sonday received her Bachelor of Science in Biochemistry and Molecular Biology from Richard Stockton College of New Jersey; Master of Science in Bioscience Regulatory Affairs from Johns Hopkins University; and Certificate in Executive Leadership from American University. This is her second year on the RAPS Convergence Planning Committee.

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