Roger Nosal is currently Principal Consultant with Roger Nosal PharmaCMC Regulatory Consultants and serves as Head of Regulatory Strategy for NGT BioPharma Consultants. Prior to September 2022 he was Vice President & Head of Global Chemistry, Manufacturing & Controls at Pfizer where he was accountable for development, preparation & prosecution of global regulatory CMC applications for new commercial products & investigational applications (small & large molecules, combination products, vaccines including the COVID-19 mRNA vaccines and gene/cell therapies).
Roger is currently Rapporteur for the ICH QDG and has served as PhRMA representative to several ICH EWG & IWGs. Roger was instrumental in development & implementation of Quality by Design & was awarded the Pharmaceutical Discovery, Development and Manufacturing Forum Award from AIChE for outstanding contributions to advancing QbD in 2013. He has been an invited speaker/expert panelist (>230) on a myriad of CMC development/regulatory topics including technical innovations (continuous manufacturing, PAT & adaptive controls). Roger’s 41 years of experience at G. D. Searle, Monsanto, Pharmacia & Pfizer, includes 28 years in regulatory CMC & 13 as a Medicinal & Process Chemist & author of 24 patents.