Timothy J.N. Watson PhD

Executive Director & Team Leader, CMC Advisory Office, Pfizer Inc

Dr. Timothy Watson, PhD is an Executive Director and Global Leader of the CMC Advisory Office at Pfizer. The 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.