Seema Singh is a CMC Regulatory Affairs professional with extensive experience in the development, manufacturing, and global registration of biologics, antibody-drug conjugates (ADCs), monoclonal antibodies, and other complex biopharmaceuticals. She has worked on regulatory submissions and CMC strategies across multiple global health authorities, including FDA, EMA, PMDA, and other international agencies. Throughout her career, she has supported INDs, BLAs, NDAs, lifecycle management, comparability strategies, process validation, analytical development, and CTD Module 3 authoring. She Is Based in Tokyo, Japan