Shannon DiNapoli has worked in regulatory affairs for nearly two decades at companies including Genentech, Gilead, Portola, and Zogenix. Her experience spans the product lifecycle from pre-IND through post-marketing and commercial regulatory affairs. Over the course of her career, she is worked on three NDAs and two BLAs, including two products with REMS programs! She holds graduate and undergraduate degrees from Arizona State University. Shannon is also a proud military veteran having served 5 years in the United States Air Force, as a forward-deployed Satellite Communications Specialist. Shannon is located in the Bay Area, California.
Reporting to the Chief Scientific Officer, the Head of Global Regulatory Affairs (GRA) leads the Regulatory Affairs Department in developing and delivering innovative, breakthrough global regulatory strategies for product development and approval, in alignment with global business strategy. The Head of GRA is an experienced leader with accountability for ensuring that resources are planned and allocated to ensure that projects are implemented on time and on budget, while maintaining a high compliance standard in Regulatory department operations. Shannon is responsible for developing and leading a comprehensive and strategic approach to developing and executing integrated global regulatory strategies that account for the complex interplay between major Health Authorities (including US, UK/EEA, JP, and China), with a passion for clinical research in novel therapeutics to address unmet medical need and a proven record of accomplishment of success in regulatory affairs.