Roger Nosal PhD

Vice President & Head of Global Chemistry, Manufacturing & Controls, 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. 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 170 presentations at industry technical conferences. He is currently Rapporteur for the ICH IQDG & PhRMA lead to ICH M9 EWG, BCS Biowaivers, was a PhRMA CMC expert for ICH Q12 IWG & the 2013-2014 IQDG. Roger serves as the Chair of the ISPE Regulatory Steering Council & is previous Chair/Editor of Pharmaceutical Engineering (2013–2017), past Co-Chair of the DIA Quality Program Committee (2014-2017) & for 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 in the pharmaceutical community. Roger’s 38 years of experience at G. D. Searle, Monsanto, Pharmacia & Pfizer, includes 25 years in regulatory affairs. Roger testified as an expert witness at the World Court in Geneva, Switzerland & provided depositions in the US, EU and Brazil regarding patent infringement cases in 2004 & 2005. Prior to his regulatory role, Roger was a Medicinal Chemist, author of 24 patents for several medicinal candidates (PAF, leukotriene, 5-HT3 & 5-HT4 antagonists & agonists, COX-2 & serotonin inhibitors) & Process Chemist, focused on synthetic development & analytical control of derivatives of aspartame & manufacturing optimization of prostaglandin syntheses.

Appearances