Bazarragchaa Damdinsuren

Bazarragchaa (Bazaraa) Damdinsuren is a Product Quality Team Leader in the Office of Product Quality Assessment III (formerly the Office of Biotechnology Products) within the Office of Pharmaceutical Quality at CDER. He joined the FDA as a Commissioner's Fellow in 2010 and currently supervises CMC reviews for protein therapeutics across all stages of drug development and post-approval, including assessments of INDs and BLAs. He also conducts manufacturing facility pre-license inspections. Dr. Damdinsuren earned his M.D. from the National Medical University of Mongolia and his Ph.D. in cancer cell biology from Osaka University in Japan. Prior to joining the FDA, he completed postdoctoral fellowships at Osaka University and the National Institutes of Health.