Dhaval Desai is the Director of Regulatory Affairs and Supply Chain at Zydus Pharmaceuticals USA Inc. With over 15 years of experience in the pharmaceutical industry, he specializes in FDA regulatory strategy, pharmacovigilance, and supply chain resilience for the U.S. generic drug market. His responsibilities include leading regulatory strategy and approvals for generic pharmaceutical products, designing Risk Evaluation and Mitigation Strategies (REMS) for high-risk therapeutics, and serving as a key liaison to the FDA Drug Shortage Staff to safeguard access to essential medicines during periods of critical national demand. Dhaval also represents industry as a technical member of the Association for Accessible Medicines (AAM) Scientific Regulatory Advisory Working Group as well as the NDSRI working group.