Ramjay Vatsan

Brief Biosketch: 2026 Ramjay Vatsan Ph.D., CQA Associate Director (Regulatory Policy) Office of Gene Therapy, Office of Therapeutic Products/CBER/FDA 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 Phone:240-402-8364 Fax: (301) 595-1305 Dr. Ramjay Vatsan PhD is an Associate Director for Regulatory Policy in the Office of Gene Therapy, OTP in CBER/FDA. He joined FDA in 2006 and has worked as a Product Reviewer, Team Leader, and as acting Branch Chief, prior to taking up the current position. Before joining FDA, he had worked in basic and translational research at National Cancer Institute/NIH and Washington University in St. Louis. Dr. Vatsan has extensive research experience in viral and bacterial vector development, gene delivery and cancer immunotherapy. Dr. Vatsan is an expert in the CMC aspects of Cell and Gene Therapy and has co-authored several regulatory articles and CMC guidance documents. He represents FDA-CBER as a Cell and Gene Therapy expert in various international forums such as ICH, EDQM and APEC. Dr. Vatsan is an ASQ Certified Quality Auditor and a full-time CMC Master Reviewer at FDA.