Piyush Modi is Director of Regulatory Affairs (CMC) at Amneal Pharmaceuticals with more than 20 years of experience in pharmaceutical development, regulatory strategy, and Chemistry, Manufacturing, and Controls (CMC). He has led regulatory strategies supporting NDA, ANDA, and lifecycle management programs across multiple therapeutic areas and dosage forms, working closely with FDA and global regulatory agencies on complex manufacturing and compliance matters.

Piyush’s areas of expertise include regulatory intelligence, inspection readiness, quality systems, manufacturing controls, technology transfer, and risk-based regulatory strategy. He is an author of multiple regulatory science publications, a peer reviewer for scientific journals and conferences, and an invited speaker on topics including regulatory intelligence, artificial intelligence in regulatory affairs, and pharmaceutical quality systems. His recent work has focused on applying data-driven approaches to improve submission quality, regulatory decision-making, and first-cycle approval success.