Roger Nosal, Head of Global Regulatory Strategy and Submissions

Roger NosalRoger Nosal is Principal Consultant with Roger Nosal PharmaCMC Regulatory 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).

Expertise:

  • Contributed to the evolution of Quality by Design & has advocated for global regulatory harmonization through several ICH, PhRMA, ISPE, PQRI, AAPS, IFPAC, ACS & DIA technical committees.
  • 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.