Novavax appoints new vice president of regulatory affairs
As vice president of regulatory affairs, Fix will be responsible for directing regulatory strategy and coordinating Novavax's interactions with regulatory agencies for the development and commercialization of vaccine product candidates. Novavax uses recombinant nanoparticle technologies to create vaccines to combat infectious diseases around the world.
"Amy has considerable expertise in the development of novel vaccines and will be an important guide for us as we advance our vaccine candidates through regulatory review," Stanley Erck, the president and CEO of Novavax, said. "She will play an integral role in supporting our clinical development programs, coordinating our interactions with regulatory agencies and preparing us for the commercial launch of our vaccine product candidates. I welcome her to Novavax and look forward to her contributions to our future success."
Prior to joining Novavax, Fix held regulatory affairs positions at multiple leading vaccine pharmaceutical companies, including MedImmune and Baxter International. While at Baxter, Fix led the regulatory strategy for seasonal and pandemic affairs under a contract with with the Biomedical Advanced Research and Development Authority.
Her last job before taking the position with Novavax was as the senior director of regulatory affairs at Emergent Biosolutions, where she was responsible for the international licensure of the company's anthrax vaccine and for the management of regulatory activities connected with its BARDA-supported advanced manufacturing and development program.