Regulatory Affairs CMC, AbbVie Inc.
AbbVie
Ana Sengupta, Senior Manager in Regulatory Affairs-CMC at AbbVie Inc. has about 24 years of professional experience in the field of Biotechnology and the Pharmaceutical Industry, out of which 12 years of direct experience working in Regulatory Affairs. Before joining AbbVie, she had worked in various capacities in the Research and Development area of drugs and biologics in midsize to large, multi-national pharma/biotech firms such as Novartis, Genentech, and AstraZeneca. She has experience in regulatory requirements for early and late stages of drug development for both small molecules (New Chemical Entity) and large biomolecules (New Biologic Entity), indicated for several therapeutic areas such as oncology, hematology, cardiovascular/metabolic, neuroscience, etc. She has regulatory filing and product approval experience in the US as well as global markets for both small molecules and biologics. She has experience in the lifecycle management of drug products, assessing and evaluating post approval changes, authoring, and reviewing regulatory submission documents for IND, IMPD, NDA, and BLA. She is passionate about bringing safe and effective drugs to patients.
She has a Master of Science Degree in Microbiology from Nagpur University, India, a Master of Science Degree in Chemistry from the University of Nebraska, Lincoln, and an MBA degree in Healthcare Management Business Administration from Paul Merage School of Business at the University of California, Irvine. She has also earned a Project Management Certificate from the University of California, Berkeley, CA, a Regulatory Affairs Certificate from the University of California, Santa Cruz, CA and a RAPS Regulatory Affairs Certification, RAC (US) since 2018. She enjoys volunteering for RAPS San Francisco Chapter Community to help grow our chapter..
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Monday, September 12, 2022
2:00 PM – 3:00 PM MST