Roger Nosal

Roger Nosal is the Senior Vice President & Head of Regulatory Affairs and Quality Assurance for Vaxcyte, Inc. He is also the Principal Consultant for Roger Nosal PharmaCMC Regulatory Consultants, LLC supporting The Blackstone Group. For 12 years prior to September 2022, he was Vice President and Head of Global Chemistry, Manufacturing and Controls at Pfizer where he was accountable for all global regulatory CMC strategies and applications for innovative products and medical devices. Roger led development of the CMC regulatory strategy and negotiated clinical and commercial requirements with global regulatory authorities for authorization/approval of the first mRNA vaccines to effectively address the COVID-19 virus. From 2018 – 2023 Roger served as Rapporteur for the ICH Quality Discussion Group and has been a contributor to several ICH Quality and Multi-disciplinary Expert Working Groups since 1994 including, most recently, ICH M9 – BCS Biowaivers. Roger was instrumental in development and implementation of Quality by Design and, in 2013, was awarded the Pharmaceutical Discovery, Development and Manufacturing Forum Award from AIChE for outstanding contributions to advancing QbD. In 2024 Roger was awarded the ISPE Richard B. Purdy Award for Distinguished Achievement that recognizes significant, long-term achievements to ISPE. Roger’s 44 years of experience at G. D. Searle, Monsanto, Pharmacia, Pfizer and Vaxcyte includes 31 years in regulatory CMC and 13 years as a Medicinal and Process Chemist. He is co-author of 24 patents. He has publicly presented and published on a wide variety of regulatory and pharmaceutical policy initiatives and topics.