Dr. Timothy Watson, PhD, Senior Director, GCMC Advisory Office at Pfizer. 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 is also one of Pfizer’s participating Boards of Directors for the International Consortium for Innovation and Quality (IQ) and serves as the Co-Chair of the ISPE Global RCC – North American Regional Focus Group. Tim’s primary responsibility at Pfizer is to collaborate with Regulatory CMC team leaders, Co-Development teams (technical teams), and Pfizer Global Supply (PGS) teams from Small Molecule (API and DP), Biotherapeutics, Vaccines, etc. on a number of regulatory and technical issues. He helps provide strategy with an impact across Pfizer’s portfolio, including (but not limited to): quality by design (QbD), control strategy, criticality analysis, ICH expert, review of relevant draft guidelines and regulations, regional advocacy (e.g., Asia), etc. 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.