Ganapathy Mohan, Ph.D — CMC Regulatory Strategies

Mohan retired from Merck in December 2022 and has worked in the pharmaceutical industry for about 40 years. He has a Ph.D in Analytical Chemistry from Kansas State University.

At Merck, Mohan held several leadership roles, including Head of Global External Advocacy, Head of Global Research/Development Quality, and Head of Global CMC Regulatory Affairs.

Prior to joining Merck, he served as Associate Vice President of the Global Analytical Sciences Department at Sanofi, overseeing CMC Regulatory Coordination and Research Quality Control. Additionally, he was the U.S. Head of R&D Quality Assurance (GCP, GLP, GMP, and Computer Systems Validation) for several years.

Until March 2023, Mohan was the PhRMA Topic Lead for the ICH Expert and Implementation Working Groups for ICH Q13, responsible for the guideline on Continuous Manufacture of Drug Substances, published in December 2022. He also led the PhRMA Nitrosamines Task Force, representing nearly 20 global pharmaceutical companies until the end of 2022. He is recognized as a global expert (KOL) on this critical and complex topic.

Mohan also led the PhRMA Core Team on Accelerated Global Drug Approvals, participating in meetings with both the FDA and EMA. He has served on the USP Council of Experts, chaired the AAPS Regulatory Sciences Section, and led the IQ Consortium’s Quality Coordinating Council.

At Merck, Mohan spearheaded several high-impact global projects. Notable examples include supporting BREXIT-related initiatives, establishing a council to manage development in China, leading the Global Nitrosamines Team on Risk Assessment (covering Merck’s entire portfolio of small molecules, biologics, and vaccines), and driving external advocacy efforts with global regulatory authorities. These efforts have contributed to positive regulatory approaches that benefit the pharmaceutical industry.