Andrew Chang

Novo Nordisk Inc.

Dr. Andrew Chang has more than twenty-five years of experience in the development, regulation and quality of biologics, pharmaceuticals, and combination products. At his current capacity as a Vice President, Quality and Regulatory Compliance, Novo Nordisk Quality, he is responsible for external affairs, providing strategic advice and solutions for quality and regulatory related issues, and expert support to inspection preparation. Since 2013, Andrew has represented Novo Nordisk at several work groups in industry trade organizations, e.g., PhRMA, BIO and EFPIA to advocate patient and industry’s interests by developing position papers and participating liaison meetings with the regulatory authorities. For example, 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 Novo Nordisk, Andrew had served more than eleven years at 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). While at FDA, Andrew was known as a leading FDA and CBER spokesperson and has presented the FDA perspective at many national and international meetings. He also served as the FDA deputy topic leader for developing ICH Q5E guideline and the FDA observer for European and US Pharmacopeia’s Expert Groups on Blood and Blood Derived Products. During his tenure in the FDA, Andrew received numerus high level FDA awards for his exceptional and outstanding performance on regulatory review and management, GMP inspection, and policy.