Steve Kradjian

Steve Kradjian, RAC, is responsible for regulatory leadership in the development of biologic and medical device components of all ViaCyte product candidates. Mr. Kradjian is a regulatory affairs leader with more than 25 years of experience in clinical, nonclinical and CMC regulatory affairs disciplines for cell therapies, medical devices, biologics, small molecules, macromolecules, and combination products in a wide range of therapeutic areas. Prior to ViaCyte, Mr. Kradjian was founder and principal consultant at a full-service regulatory CRO, where he led domestic and international regulatory teams to multiple U.S. product approvals. He led the successful filing of several NDAs and INDs in the United States and CTAs in Canada and Europe as well as pre-submission/scientific advice and strategic meetings with health authorities in these regions. Previously, Mr. Kradjian was Executive Director of Regulatory at Vical and held positions of increasing responsibilities at American Medical Optics and Amgen. He earned a B.A. in chemistry from Occidental College and completed the Executive Development Program in regulatory affairs at The Kellogg School of Management.