Roger Nosal MA Pfizer

Roger Nosal is an independent consultant, formerly, Vice President & Head of Global Chemistry, Manufacturing & Controls at Pfizer where he was accountable for development, preparation & prosecution of regulatory CMC applications for new commercial products & investigational applications (small & large molecules, combination products, vaccines, gene/cell therapies) globally including COVID-19 mRNA vaccine. Roger was instrumental in development & implementation of Quality by Design & has advocated for global regulatory harmonization & mutual reliance as PhRMA representative to several ICH Expert & Implementation Working Groups since 1997 & through more than 190 presentations at technical conferences. He is currently Rapporteur for ICH QDG & PhRMA lead to ICH M9 EWG, BCS Biowaivers, & PhRMA CMC expert for ICH Q12 IWG & the 2013-2014 QDG. Roger served as Chair to several PhRMA, ICH, ISPE, PQRI, AAPS, IFPAC, ACS & DIA technical committees. In 2013 Roger was awarded the Pharmaceutical Discovery, Development and Manufacturing Forum Award from the American Institute of Chemical Engineers (AIChE) for outstanding contributions to advancing QbD. Roger’s 41 years of experience at G. D. Searle, Monsanto, Pharmacia & Pfizer, includes 27 years in regulatory affairs & 13 as a Medicinal & Process Chemist and author of 24 patents.