SUNITA SETHI, PHARM.D., R.PH.
Senior Vice President, Global Regulatory Affairs
Dr. Sethi has over 30 years of experience across all stages of drug development, from preclinical studies to post-approval lifecycle management. Her career includes roles at large pharmaceutical companies such as Johnson & Johnson, AstraZeneca, and Roche, as well as at smaller and midsize firms including Chemocentryx, Elan Pharmaceuticals, Everest BioPharma Group, and Sarah Cannon. Dr. Sethi has played a pivotal role in the approval and commercialization of over 21 novel drugs, biologics, and device combinations while building and leading high-performing teams. Most recently, she has led the development of two orphan gene therapy programs in the US and Europe, managing regulatory affairs, medical writing, and pharmacovigilance functions. She currently serves on the Board of Directors for three organizations. Dr. Sethi holds a Doctorate and a B.S. in Pharmacy and is a registered pharmacist in California and New Jersey.