Kesley E. Gallagher

Amgen
Director of External Engagement, Combination Products
Kesley Gallagher is the Director of External Engagement, Combination Products, at Amgen in Thousand Oaks, CA. She has worked in the pharmaceutical and medical device arenas for over 20 years in both Quality Assurance and Regulatory Affairs. Her prior responsibilities include Medical Device Regulation (MDR) implementation for both CE marked devices and products that will require notified body opinion. She led teams for the global submissions and approvals for the Repatha Pushtronex and managed the regulatory aspects of the Neulasta OnPro; these are Amgen’s first on-body injectors. Prior to joining Amgen, Kesley was an RA Manager at Abbott Medical Optics, specializing in new product development for eye care products and ophthalmologic surgical femtosecond lasers. Kesley has an MS in Regulatory Science from the University of Southern California and an BA in Biology/Chemistry from Bowdoin College.