Anamitro Banerjee
Director, CMC Regulatory Affairs @ AstraZeneca
United States
Olney
Pharmaceuticals
Conflict Resolution, Committees, Interpersonal Skills, Regulatory Strategy, Strategic Thinking, Organic Synthesis, Organic Chemistry, Biochemistry, Spectroscopy, Chemistry, Medicinal Chemistry
Experience
Director, CMC Regulatory Affairs
AstraZeneca
Gaithersburg, Maryland, United States
Branch Chief, ONDP
FDA
Washington D.C. Metro Area
Our branch reviews the quality sections of all INDs and NDAs for small molecules submitted to the 5 oncology divisions (DO1, DO2, DO3, DHM1, and DHM2) in OND, CDER. We support several Oncology Center of Excellence (OCE) initiatives including Project Orbis and Real Time Oncology Review (RTOR). The Branch uses the Product Quality Assessment Aid (PQAA) to review the Quality sections of these NDAs.
Acting CMC Lead
FDA
Washington D.C. Metro Area
Point of contact for the OPQ for all pre-marketing CMC related interactions with the Division of Transplant and Ophthalmology, OND, and external entities.
Senior Chemist
FDA
Washington D.C. Metro Area
Chemist
FDA
Faculty
University of North Dakota
Postdocotral Fellow
Cornell University
Education
University of Maryland
Chemistry
Indian Institute of Technology, Kharagpur
Chemistry
St. Xavier's College (Autonomous), Kolkata
Chemistry
Kendriya Vidyalaya
Anamitro Banerjee's Contact Information
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