VP Regulatory Affairs and Quality
Joanne Totosy de Zepetnek PhD, Vice President Regulatory Affairs and Quality, Rhythm Pharmaceuticals, Inc.
Senior regulatory affairs professional with 30 years drug development experience covering clinical, nonclinical and CMC disciplines. Accomplished leader of project teams across all phases of development from discovery through post-marketing life cycle management, focusing on optimal product development, positive regulatory actions, and planning for successful commercialization. Cross-therapeutic experience includes vaccines, inflammation, rare diseases, metabolism/endocrine, transplantation, oncology, and medical devices.
Extensive experience working in complex matrixed environments, developing global regulatory strategies, interpreting international regulatory requirements, and delivering high quality regulatory documents and submissions under aggressive timelines. Proven track record of positive interactions with key global health authorities as company liaison at health authority meetings in the USA, Europe, Japan and Canada as well as during health authority pre-approval site inspections. Responsibilities have also included hands-on management of documentation in support of clinical investigational applications and marketing applications, building and integrating programs in compliance with GXP, and overseeing technology transfer of manufacturing operations. Highly regarded by senior management, peers, and direct reports for integrity, critical thinking, strong bias for action, and the ability to build effective solutions to complex regulatory issues.
Wednesday, September 16, 2020
10:35 AM – 11:30 AM EDT