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.