Roger Nosal

Pfizer, Inc.

Roger Nosal is Vice President & Head of Global Chemistry, Manufacturing & Controls at Pfizer. He is 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. Most notably he has been responsible for CMC regulatory strategies for the mRNA platform that produced the first effective vaccine for the COVID-19 virus.

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 (EWG & IWG) since 1997 & through more than 180 presentations at industry technical conferences. He is currently Rapporteur for the ICH QDG & was PhRMA lead to ICH M9 EWG, BCS Biowaivers & CMC expert for ICH Q12 IWG & the 2013-2014 IQDG. Roger has 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 40 years of experience at G. D. Searle, Monsanto, Pharmacia & Pfizer, includes 26 years in regulatory affairs & 13 as a Medicinal & Process Chemist and author of 24 patents.