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Arundhati Sengupta, MS, MBA, RAC

Director, Regulatory Affairs CMC
Mirum Pharmaceuticals

Arundhati Sengupta, Director in Regulatory Affairs at Mirum Pharmaceuticals, Inc. She has more than 25 years of pharmaceutical industry experience and 15 years of direct experience in regulatory affairs of drugs and biologics. Before working at Mirum Pharmaceuticals, she worked in various capacities in regulatory affairs strategy and CMC in AbbVie, Novartis, Genentech, and AstraZeneca. She leads product lifecycle management, preparing submission-ready documents for IND, IMPD, NDA, BLA, and MAA. She has extensive experience in global change management, global submissions, interactions with health agencies, and securing approvals based on science-based approaches and local regulations. She also leads in regulatory intelligence by critically analyzing trends of hot topics to determine industry standards and the current thinking of health authorities. She is passionate about bringing safe and effective drugs to patients.

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