Robert Metcalf, Ph.D.

Vice President, Global Regulatory Affairs – US & Global Medical QualityRobert is Vice President, Global Regulatory Affairs – US and Global Medical Quality.  He is responsible for interactions with the FDA supporting new drug development and marketed products, including US product labeling, advertising and promotion, and regulatory policy.  Robert also has responsibility for, global label management, global submission management, and global Chemistry, Manufacturing and Control for Lilly.  He also has responsibility for the Quality organizations supporting clinical development, regulatory, and product safety. After completing his Ph.D. in Pharmacology and Toxicology at Queen’s University in Canada, Robert joined Eli Lilly Canada in the Regulatory Affairs organization where he led successful approval efforts, for neuroscience and anti-infective new chemical entities.  His next opportunity led him to the Lilly Corporate Center in Indianapolis where, as a member of the Global Project Management organization, he led cross-functional teams in the global development and registration of new molecular entities in Lilly’s diabetes and osteoporosis portfolios.  Following this opportunity, Robert returned to Lilly Canada where he had leadership responsibility for Regulatory Affairs, Health Outcomes, and Quality.  In 1998, Robert was transferred to Japan where he led the Project Management and Pharmaceutical Development organizations for Lilly Research Laboratories, Japan...
Source: PHRMA - Category: Pharmaceuticals Authors: Source Type: news