Vice President, Global Regulatory Policy and Intelligence, Janssen Inc.
Ginny is VP, Global Regulatory Policy and Intelligence at Janssen Pharmaceuticals. She leads Janssen’s Global Regulatory Policy efforts, working to shape the regulatory environment to support innovative drug development and patient access to new therapies. Previously Ginny led the Global Regulatory and R&D Policy group at Amgen, working on issues related to trial design, real world data, companion diagnostics, combination products, and other topics. Ginny joined Amgen from Eisai, where she led the Global Regulatory Policy team for 8 years. She was the Executive Director/Special Counsel, Regulatory Strategy and Law, and a member of the GRA and Legal Departments. Ginny previously worked at Genentech as Director, Regulatory Policy and Strategy.
Before Genentech, Ginny was at the Center for Drug Evaluation and Research (CDER), FDA where she was the Director, Division of Regulatory Policy II, Office of Regulatory Policy, for 8 years. She was responsible for the development of all regulations affecting CDER, crafting policy positions in areas such as biosimilars. Before that, Ginny was a US Army JAG, was prosecutor and appellate attorney. Ginny is an RN and started her career as an ICU in the US Air Force. Ginny holds B.S.N. and J.D. degrees from the University of Virginia.