Andrew Chang PhD Novo Nordisk

Dr. Andrew Chang is a multifaceted quality and CMC leader with 28 years well-rounded medical product regulatory and industry experiences. He is a board of director for PDA and CASSS-Sharing Science Solutions, respectively. 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. He has served ICH Q5E/Q12/Q6(R1) EWGs. Prior to industry, Andrew had served more than 11 years in US FDA most recently as an Associate Director for Policy and Regulation in the Division of Haematology, CBER. He was responsible for management of marketing application review and inspections in the Division. 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 post-doctor in immunology from the National Institutes of Health, 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 and has been a frequent speaker at national and international conferences.