Anamitro Banerjee

Director, CMC Regulatory Affairs at AstraZeneca

Anamitro Banerjee is an experienced professional in the field of chemistry and regulatory affairs, currently serving as the Director of CMC Regulatory Affairs at AstraZeneca since March 2022. Prior to this role, Anamitro held various positions at the FDA from September 2008 to March 2022, including Branch Chief for the Office of New Drug Products (ONDP), where oversight included quality sections of INDs and NDAs for oncology divisions and support for initiatives like Project Orbis and Real Time Oncology Review. Additional roles at the FDA included Acting CMC Lead, overseeing interactions related to pre-marketing CMC with external entities, and earlier positions as Senior Chemist and Chemist at the University of North Dakota. Anamitro's academic background includes a Ph.D. in Chemistry from the University of Maryland, an MSc from the Indian Institute of Technology, Kharagpur, and a BSc (Hons) from St. Xavier's College, Kolkata.

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