Ramjay Vatsan, PhD

Dr. Ramjay Vatsan is an Associate Director for Regulatory Policy in the Office of Gene Therapy, OTP in CBER/FDA. Since joining CBER in 2006, he has held roles as 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 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 has co-authored several regulatory articles and CMC guidance documents. Dr. Vatsan represents CBER/FDA as a cell and gene therapy expert in international forums such as EDQM (European Directorate for Quality of Medicine), ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use). He is a CBER technical expert and contributes to policy development activities at FDA. Dr. Vatsan is an ASQ Certified Quality Auditor and a full-time CMC Master Reviewer at FDA.