Pujita Vaidya
Director, Regulatory Science & Policy 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
- Aligning PFDD and RWE across regulators, payers, and HTAs to build a unified, patient-centered evidence strategy that supports regulatory decisions and reimbursement requirements
- Demonstrating stakeholder impact through patient-driven evidence, quantifying benefit–risk, payer value, and HTA relevance using data that resonates across decision-makers
- Tracking KPIs that link patient engagement to regulatory and market success, showing improvements in submissions, launch readiness, payer value propositions, and time-to-market
- Embedding patient insights across evidence generation and access pathways, from trial design and labeling discussions to regulatory dossiers, HTA submissions, and global launch optimization
