Jihye Nam

Jihye Nam is a CMC Regulatory Affairs Regulatory Lead at Astellas Pharma, supporting Cell Therapy and Biologics programs across development and lifecycle management. She leads CMC regulatory strategy for advanced biologic programs, with a focus on enabling accelerated development while ensuring global regulatory compliance. She brings over eight years of combined experience in Quality Assurance and CMC Regulatory Affairs, with a background spanning GMP quality systems, regulatory strategy, and cross-functional collaboration across technical, manufacturing, and quality organizations. An ISPE Emerging Leader, Jihye is actively engaged in advancing regulatory innovation, digital transformation, and knowledge-sharing within ISPE community.