Andrew Chang PhD Novo Nordisk

Andrew Chang PhD

Andrew Chang PhD Novo Nordisk VP, Quality and Regulatory Compliance

Dr. Andrew Chang is a multifaceted quality and CMC leader with 25 years well-rounded medical product regulatory and industry experiences. He is the chair for PDA Biopharmaceutical Advisory Board (BioAB) and a board of director for CASSS-Sharing Science Solutions. At his current capacity as a Vice President, Quality and Regulatory Compliance, Regulatory Policy and Intelligence, Global Regulatory Affairs, Novo Nordisk, he provides strategic leadership on Regulatory and Quality related Policy, External Affairs, strategic advice and solutions to quality and regulatory related challenges. 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, CBER. Andrew received numerus high level FDA awards for his exceptional and outstanding performance on regulatory review and management, GMP inspection, and policy. Andrew’s formal scientific training includes Ph.D. in Biochemistry from the State University of New York, and B.S. in Pharmaceutical Chemistry from the China Pharmaceutical University. He has published numerus peer reviewed scientific papers in JAMA, J.Exp.Med., Blood, J.Immunol., Dev. Immunol. Thromb Haemost., Haemophilia, Pharmaceutical Engineering etc., and has been a frequent speaker at national and international conferences.