Roger Nosal

Head of Global Regulatory Strategy and Submissions, NGT Biopharma

Roger Nosal is currently Principal Consultant with Roger Nosal PharmaCMC Regulatory Consultants and serves as Head of Regulatory Strategy for NGT BioPharma Consultants, a consortium of experienced experts and leaders in development of pharmaceutical products. 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 was responsible for negotiating 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 representative to several ICH Expert Working Groups since 1994. 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. Roger’s 41 years of experience at G. D. Searle, Monsanto, Pharmacia and Pfizer includes 28 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.