Dedicated Regulatory CMC and Program Management professional with 10+ years of experience in regulatory strategy, cell and gene therapy program development, orphan drug regulations (ODD) and global health regulations, which spans in multiple therapeutic areas: monogenic rare diseases, CNS, oncology, hematology, and rheumatology. Expert IND/IMPD/DMF/CTA/BLA author. Proven leadership and managerial expertise in driving early to late development teams (resulting in successful IND, CTA, BLA, DMF, IMPD, MAA submissions) and product life cycle development programs (directing and managing life cycle activities for INDs, BLAs and MAAs) through complex milestones and tight timelines. Proven, progressive track record for working independently and in matrix teams successfully in fast-paced, results-driven, highly accountable environment with large potential impact; ability to prioritise and manage multiple tasks simultaneously, integrate cross-functional issues, and balance competing priorities effectively, with strong analytical, problem solving and critical thinking skills, including ability to combine attention to detail with a big picture perspective.