Timothy J.N. Watson
Vice President – Head of CMC Regulatory Affairs, Gilead Sciences
Dr. Timothy Watson, Ph.D. is Vice President-Head of CMC Regulatory Affairs, Gilead Sciences. Prior to Gilead, Tim lead Pfizer' CMC Advisory Office is a collection of global Pfizer technical and regulatory experts that provide guidance & direction to project teams to mitigate regulatory risk & integrate CMC policy with product strategies; while developing and advocating policy positions (internally and externally) in conjunction with QO. The Advisory Office includes in region team members to support AFME, LATAM, A-Pacific portfolio execution and CMC policy, including the Pfizer’s China’s CMC product portfolio team. In addition to Advisory Office responsibilities, Tim has been instrumental in development & implementation of Quality by Design, ICHQ12, etc. & continues to advocate for global regulatory harmonization & mutual reliance serving as a PhRMA representative to several ICH Expert & Implementation Working Groups (EWG & IWG) since 2009. Tim served as a PhRMA EWG member on the ICHQ11 regulatory guidance document for drug substance, the Rapporteur for the ICHQ11 Q&A Starting Material IWG, PhRMA IWG member for the ICHQ7 Q&A team and continues to serve as the PhRMA ICHQ3C EWG lead. Recently, Tim has been nominated to serve as the PhRMA IWG/ EWG lead for ICHQ9 revision (starting in 2020). Tim serves on the Boards of Directors for the International Consortium for Innovation and Quality (IQ), Co-Chairs the ISPE Global Regulatory and Quality Harmonization Council/ and member of Regulatory Steering Committee and appointed as the Pfizer’s lead representative on the PhRMA Global Quality and Manufacturing Work Group (GQM WG). Tim has numerous publications, presentations, and received numerous awards for regulatory contributions (e.g. AAPS Regulatory Section Recognition Award in 2014).
Tim began his career at Marion Merrell Dow (1994) in chemical research and development (CRD) as a API small molecule process chemist, where his responsibilities involved developing new API processes, manufacturing the first GMP API bulk clinical supplies, and technology transfers to commercial facilities/ CROs, etc. In 2000, Tim joined Pfizer, where he continued with process chemistry development responsibilities with a focus on post proof of concept projects and commercialization up until 2009 when he joined CMC. Tim holds a Ph.D. from The Ohio State University, under the direction of Dr. Leo Paquette.