Ramjay Vatsan PhD, CQA

Dr. Ramjay Vatsan PhD is an Associate Director for Regulatory Policy in the Office of Gene Therapy, OTP in CBER/FDA. He joined CBER in 2006 and has served as a Team leader in the Gene Therapy Branch, Acting Branch Chief in the Cell Therapy Branch before taking up his current position. Prior to 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. Dr. Vatsan is an ASQ Certified Quality Auditor and a full-time CMC Master Reviewer at FDA.