Anamitro Banerjee PhD AstraZeneca

Anamitro Banerjee has been with AstraZeneca since March 2022, and is currently a Director in CMC Regulatory Affairs, AstraZeneca. His duties include global CMC regulatory strategy for development and commercial health authority submissions, as well as serving as a key contributor to several ongoing internal and external initiatives. Prior to joining AstraZeneca, he was a Branch Chief, Division of New Drug Products I in ONDP, OPQ, CDER, FDA, where his branch supported all the five oncology clinical divisions for CMC evaluations of small molecules in investigational and new drug applications. He actively supported the Oncology Center of Excellence (OCE) in all the initiatives such as Real Time Oncology Review (RTOR), Project Beyond Breakthrough, and Project Orbis. Prior to this role, he was a Quality assessment lead for ONDP supporting the Division of Transplant and Ophthalmology Products (DTOP) and a CMC reviewer for post marketing applications. Prior to joining the FDA, he was a tenured faculty member at the University of North Dakota, Grand Forks. He is trained as an organic chemist (PhD, University of Maryland) and has spent nearly 2 years as a postdoctoral associate at Cornell University.