Penny Levin leads the new regulatory intelligence function at Cephalon where she provides analysis of the regulatory environment; including review of and
developing Cephalon interpretation on forthcoming legislation and guidance that impact drug development and then training internal personnel to assure
understanding and compliance with the new regulations. In this role, Penny also provides strategic guidance to the product development teams by using
regulatory intelligence as a tool for better decision-making. Penny also represents Cephalon on the BIO Regulatory Affairs and PDUFA V workings groups in
efforts to assure that FDA legislation and guidances that impact drug development are developed with appropriate input from industry.
Penny has more than 20 years experience as a regulatory affairs and clinical research professional. Prior to starting up the regulatory intelligence function,
Penny was the Regulatory Director for multiple drugs in the pain franchise at Cephalon. Prior to joining Cephalon, Penny has had tenure at major
pharmaceutical companies including AstraZeneca and SmithKline, as well as spent a number of years at Hurley Consulting where she provided drug development counsel to numerous pharmaceutical and biotech companies worldwide. While at AstraZeneca, Penny brought the Temple University Graduate School of Pharmacy Master’s Degree program in Regulatory/QA on-site to provide employees an opportunity to obtain their graduate studies while still on campus. This program is still ongoing today.
Penny holds a Masters of Science in biostatistics from New York Medical College and is an alumni of Harvard Business School where she completed the
General Management Program.
EVENTS & ACTIVITIES (Speaking, Spoken, and Authored)