Pujita Vaidya has over 13 years of experience in regulatory science and policy and is a leader in advancing patient-focused drug development across the medical product lifecycle. She serves as Regulatory Science and Policy Director at Sanofi, where she develops and advocates for regulatory policy positions, collaborates across functions to advance strategic plans, and engages with regulators, industry, patient advocates, professional associations, and other stakeholders. Pujita co-chairs BIO’s Patient-Focused Drug Development Taskforce, leading strategic efforts to advance the systematic collection and meaningful incorporation of patient experience data throughout the medical product development and regulatory decision-making lifecycle. Previously, she held positions at Novartis as U.S. Patient Engagement Director and at Amgen as Global Regulatory and R&D Policy Director. Before joining industry, Pujita spent over seven years at the FDA, where she served as CDER’s expert to advise leadership, lead key initiatives, and provide strategic and regulatory guidance to advance the incorporation of patient input into regulatory decisions. She led FDA’s PFDD Program, developed and implemented CDER’s Benefit-Risk Framework, and represented FDA on the ICH Management Committee, contributing to international harmonization efforts. Pujita earned her MPH from Johns Hopkins Bloomberg School of Public Health and her BA in Biochemistry from Wheaton College.