Full Name
Dr. Andrew Chang
Job Title
VP, Quality and Regulatory Compliance, Regulatory Policy and Intelligence, Global Regulatory Affairs
Hospital/Organisation/Company
Novo Nordisk,
Speaker Bio
Dr. Andrew Chang is a multifaceted quality and CMC leader with 30 years well-rounded medical product regulatory and industry experiences. He is a board of director for CASSS-Sharing Science Solutions and PDA, 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.
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. He was responsible for management of marketing application review and inspections and had led CBER effort to develop international standards. Andrew received numerus high level FDA awards for his exceptional and outstanding performance on regulatory review and management, GMP inspection, and policy.
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. He was responsible for management of marketing application review and inspections and had led CBER effort to develop international standards. Andrew received numerus high level FDA awards for his exceptional and outstanding performance on regulatory review and management, GMP inspection, and policy.
