Session – Development to Registration – challenges for Regulatory Affairs in global environments Subhadip Jana is a regulatory affairs leader with extensive experience in global regulatory strategy, planning and successful market access. He has proven expertise in managing complex Health Authority interactions; providing registration strategy for global products; improving regulatory process and compliance, and leading global submissions (NDA, MAA, BLA, IND, Briefing Books etc.). He led regulatory affairs in many cross-functional activities related to regulatory strategy, stakeholder communication, submission documents, regulatory compliance and collaboration with teams from early drug development to post-approval for compounds in Oncology, Gastroenterology, CNS therapeutic areas. He is passionate about improving the life of patients