Andrew Chang Novo Nordisk

Dr. Andrew Chang is a multifaceted quality and CMC leader with 25 years well-rounded medical product regulatory and industry experiences. He is skilled in interpersonal relationships combined with knowledge of science and law which is used to bring about impactful data-driven and risk-based decision-making process and results. At his current capacity as a Vice President, Quality and Regulatory Compliance, Novo Nordisk Quality, Novo Nordisk, Inc. he is responsible for external affairs, providing strategic advice and solutions for quality and regulatory related issues, and expert support to inspection preparation. Since 2020, Andrew has served as the vice-chair for PDA Biopharmaceutical Advisory Board. He is a member of PhRMA and BIO’s International Regulatory Policy Work Groups and representing PhRMA as an expert and topic leader to ICH Q12 Expert Work Group and implementation work group, respectively for developing and implanting guideline on Pharmaceutical Products Lifecycle Management. Prior to industry, Andrew had served more than 11 years in US FDA most recently as an Associate Director for Policy and Regulation, Acting Deputy Director, Lab Chief and Senior Regulatory Scientist in the Division of Hematology, Center for Biologics Evaluation and Research (CBER).