Pradnya Bhagwat

Regulatory Affairs leader with 20+ years of experience guiding global drug development from early clinical phases through FDA and EMA approvals. I specialize in regulatory strategy, agency interactions, major submissions (INDs, CTAs, NDAs, sNDAs), and post-approval lifecycle management across rare diseases, small molecules, biologics, and vaccines. I’ve led successful FDA approvals—including accelerated and full approvals for sparsentan—and manage high-stakes meetings, labeling negotiations, and REMS strategy. Known for clear communication, cross-functional leadership, and developing strong regulatory teams, I’m passionate about advancing innovative therapies and bringing clarity to complex regulatory pathways.