Carolyn Finkle has over 28 years scientific and industry experience including 18 years in management of business units, product development and commercialization, regulatory affairs, Safety/PV, MW, Operations and Compliance for companies in the U.S. and Canada, including SVP Global Regulatory Affairs, inVentiv Health, VP, Global Regulatory Affairs, Catalent Pharma Solutions, Senior Director, International Regulatory Affairs, AstraZeneca, Vice President, Global Product Development Strategy and VP North America Consulting, PAREXEL International, VP Regulatory Affairs at Celsion Corporation, VP Preclinical Development at TherImmune Research Corporation, and VP Drug Development at GeminX Biotechnologies.
Carolyn Finkle is an Adjunct Lecturer and graduate course co-director of the Georgetown University Master’s Program in Clinical and Translational Research, and faculty for UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) Graduate Course: Regulatory Considerations for Drug Development: Phase 2 and Phase 3 for Approval, and Course Director of the Pharmaceutical Education Research Institute (PERI). Carolyn has co-authored multiple white papers on Expedited Programs and Accelerated Approval, Biosimilars, a book chapter on First-in-Human global regulatory requirements, over 18 abstracts and 12 papers for industry associations and scientific publications and chaired DIA sessions (global regulatory) at the annual meetings.
Carolyn Finkle holds a M.Sc. Chemistry from the University of Toronto, Canada and has a B.Sc. Chemistry from the University of Ottawa, Canada. She has worked in academic research at Stanford University, the University of Toronto, and Chiba University, Japan, prior to her industry managerial appointments.
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