Pujita Vaidya
Director, Regulatory Science & Policy, GRA Sanofi
Pujita Vaidya has 13+ 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. She has also held key 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.
Seminars
- Embedding patient insights across the medical product lifecycle
- Aligning PFDD and patient experience data across global regulators to build a unified, patient centered evidence strategy that supports regulatory decisions.
- Demonstrating stakeholder impact through patient-driven evidence generation and quantifying benefit-risk using patient experience data that resonates with regulatory decision makers
- Tracking KPIs that link patient engagement to regulatory success, showing improvements in clinical trials and regulatory submissions
