Branch Chief (Acting), ONDP, OPQ, FDA, FDA
Dr. Banerjee currently serves as the Branch Chief (acting) in ONDP Branch 2 supporting the OHOP clinical divisions. He acted as a QAL/CMC Lead for OND’s DTOP for a year and was a CMC reviewer for NDAs and sNDAs in ONDQA since 2008. Prior to FDA, he served as a chemistry faculty...
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Vice President and Head, Regulatory CMC, Merck & Co., Inc.
Nirdosh Jagota serves as VP and Head of CMC, Global Regulatory Affairs at Merck. Nirdosh has 26 years of pharmaceutical industry experience including 21 years in global regulatory management. Prior to Merck, he was VP, Regulatory CMC at Genentech/Roche. Before joining Genentech/Roche...
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Vice President and Global Head, Regulatory CMC, Novartis Pharmaceuticals Corporation
Diane Zezza is Vice President and Global Head Regulatory Affairs, CMC at Novartis Pharmaceuticals. Diane has global responsibilities for CMC regulatory strategies/submissions for all development and lifecycle products. Diane has been a speaker at conferences on regulatory topics including...
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