Chief Regulatory Officer

Amy Fix

Ms. Fix is Chief Regulatory Officer with responsibility for regulatory strategy and interactions with global regulatory agencies, which oversee the development and commercialization of Vaxxinity’s vaccine candidates. Prior to joining Vaxxinity, Ms. Fix was Senior Vice President of Regulatory Affairs and Quality at Arcellx and a Principal Consultant for Scendea, a regulatory consulting firm.  Prior to joining Arcellx in September 2019, Ms. Fix was Senior Vice President of Regulatory Affairs and part of the Senior Management team at Novavax, leading the development of multiple late-stage vaccine development programs, including a Phase 3 global maternal immunization clinical trial being conducted in 11 countries, and two Phase 3 older adult programs for the RSV and influenza franchises.  Prior to joining Novavax in April 2013, she was Senior Director of Regulatory Affairs at Emergent Biosolutions after serving in Regulatory Affairs positions of increasing responsibility at a number of biotechnology/pharmaceutical companies, including Human Genome Sciences, Shire, MedImmune and Baxter. During Ms. Fix’s career, she has successfully conducted numerous global regulatory meetings, and has been responsible for multiple INDs, BLAs, NDAs, and post-marketing programs, has been a key member of business development/due diligence teams, has worked with the World Health Organization on global health initiatives, and has built successful Regulatory departments from the ground up.  Ms. Fix received her Bachelor of Science degree in Biology from the University of Illinois, her Master of Science degree in Molecular Biology from the University of Virginia’s Biotechnology program, and her Master of Business Administration degree in Management from Johns Hopkins University.