Ye Zhang

Chief Regulatory Officer at Arcturus Therapeutics

Speaker

Ye Zhang is the Chief Regulatory Officer for Arcturus Therapeutics, where she oversees the Regulatory Strategy, Regulatory CMC, Regulatory Operation and Labeling to support the development of vaccines and rare disease therapeutics. Under her leadership, the team successfully supported the COVID-19 Vaccine NDA/MAA registration with the PMDA and EMA, leading to the world's first approval of a self-amplifying mRNA vaccine. Dr. Zhang has more than 20 years of experience in regulatory and drug development for vaccines, biologics and small molecules. Prior to joining Arcturus Therapeutics, Dr. Zhang held various roles of increasing responsibility at Merck and FDA. Dr. Zhang received a Ph.D. in Pharmaceutical Sciences from the University of Colorado, and an M.D. from Peking University. Dr. Zhang is a lifetime member of the Food and Drug Administration Alumni Association (FDAAA) and serves as a board director for Alliance for mRNA Medicine (AMM).