Staff Director
Regulatory Project Management Staff / Office of Blood Research and Review / 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 Regulatory Project Management Staff (RPMS) in the Office of Blood Research and Review (OBRR), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA), helping to ensure the safety and availability of the nation’s blood supply. She has held various roles in OBRR as Staff Chief, Team Lead, and Regulatory Project Manager. She is an expert in and oversees the regulatory review and project management of meetings with industry, INDs, IDEs, ANDAs, NDAs, 510(k)s, PMAs, and BLAs. She plays a critical role in CBER, establishing procedures, providing technical training, and mentoring staff.
Before joining CBER/OBRR, Ms. Kelly 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.
Ms. Kelly 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. She has a Regulatory Affairs Certification (RAC) and is a certified Project Management Professional (PMP).
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Monday, September 12, 2022
3:30 PM – 4:30 PM MST
Tuesday, September 13, 2022
9:45 AM – 11:00 AM MST
Tuesday, September 13, 2022
2:00 PM – 3:00 PM MST