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Saroj Kumar Roy is an accomplished regulatory affairs professional with extensive experience in global regulatory strategy and CMC (Chemistry, Manufacturing, and Controls) submissions. Currently serving as Manager in Global Regulatory Affairs Innovation CMC at Elanco since January 2021, Saroj Kumar Roy leads CMC submission activities, communicates regulatory strategies, and collaborates with interdisciplinary teams throughout the product development lifecycle. Prior roles include Manager of Regulatory CMC at Eli Lilly and Company, where Saroj Kumar Roy managed regulatory submissions and authored high-quality CMC documentation, and Lead of Regulatory Affairs at iMEDGlobal Corporation, responsible for CMC regulatory matters. With foundational experience as an Executive at Mylan and as a Regulatory Associate at Novartis, Saroj Kumar Roy possesses a robust academic background with a Ph.D. in Pharmaceutical Sciences and degrees in Pharmaceutical Chemistry and Pharmaceutics.