Mehrshid Alai-Safer, PhD

Mehrshid Alai-Safer, PhD

Mehrshid Alai is VP of Global Regulatory CMC for Kite, a Gilead Company, where she is responsible for all aspects of Regulatory CMC, including development and life cycle management. Mehrshid has her Ph.D. in Biochemistry, Cell, and Molecular Biology from The Johns Hopkins University School of Medicine. Prior to Kite, Mehrshid was Interim Head of Global Regulatory CMC for Baxalta/Shire. She has over 28 years of industry experience and in her last position had the responsibility to oversee regulatory CMC aspects of all products including small molecules, biologics, complex biologics and devices. Previous to that she held various roles in R&D, Quality and Regulatory in Baxter. She is a member of Gene Therapy Working Party and USP Complex Biologics Expert Committee.