Pujita Vaidya

Director, Regulatory Science and Policy at Sanofi

Speaker

Pujita Vaidya has 14+ years of experience in regulatory science and policy and is a leader in advancing patient-focused drug development (PFDD) throughout the medical product lifecycle. Pujita serves as a Regulatory Science and Policy Director at Sanofi, working to develop, advocate for, and implement Sanofi positions on regulatory policies partnering with cross-functional colleagues across Sanofi to advance strategic regulatory policy plans, as well as engaging with regulators and external stakeholders, in key areas such as digital/AI, PFDD, novel endpoints and biomarkers. She has also held positions at Novartis and Amgen. Previously, Pujita had a 7+ year tenure at FDA as the CDER's expert to advise FDA leadership, lead key initiatives including FDA’s Patient-focused Drug Development program, and provide strategic, regulatory, programmatic, and policy advice across FDA.