Dr. Timothy Watson, Ph.D. is Vice President and Head of CMC Regulatory Affairs, Gilead Sciences. Before joining Gilead, Tim was the Executive Director and leader of Pfizer's CMC Advisory Office. The Advisory Office is a collection of Pfizer 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) for CMC regulatory/quality issues in conjunction with QO. Tim was one of the PhRMA expert working group (EWG) members on the ICHQ11 regulatory guidance document for drug substance, and the Rapporteur for the ICHQ11 Q&A Starting Material IWG. He is also served on the ICHQ7 IWG Q&A team, ICHQ3C EWG, and supporting many other ICH efforts (such as Q12). Tim also serves as a member of participating Boards of Directors for the International Consortium for Innovation and Quality (IQ) and served as the Co-Chair of the ISPE Global RCC – North American Regional Focus Group, and is a member of the ISPE International Board of Directors. Tim began his career at Marion Merrell Dow (1994) in chemical research and development as a process chemist, where his responsibilities involved developing new API processes, manufacturing the first GMP API bulk, technology transfers, etc. In 2000, Tim joined Pfizer, where he continued with process chemistry development responsibilities with a focus on post proof of concept projects. Tim holds a PhD from The Ohio State University, under the direction of Dr. Leo Paquette.