Ye Zhang is the Chief Regulatory Officer for Arcturus Therapeutics, where she establishes Regulatory Affairs department and 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 filing with the PMDA, leading to Arcturus' first drug product approval and the world's inaugural 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, where she was responsible for more than ten vaccines in development and life-cycle management and had extensive experience in working with FDA, EMA, PMDA, MHRA, NMPA and other regulatory authorities. She also worked at FDA where she reviewed more than 60 drug applications and gained extensive regulatory experience. Dr. Zhang received a Ph.D. in Pharmaceutical Sciences from the University of Colorado, and an M.D. from the Medical School of 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). Recognized for her achievements, she was named as one of the Top 25 Healthcare Technology Leaders of Pennsylvania for 2023.