Drives strategy for expedited and rare disease pathways (Breakthrough Therapy, RMAT, Fast Track, Accelerated Approval, Orphan Drug, Rare Pediatric Disease, PRIME), including surrogate and intermediate clinical endpoint strategy, natural history and external control approaches, small-population trial design, and confirmatory evidence planning. It serves as the senior regulatory strategist and primary Health Authority interface for these programs, leads a team of Global Regulatory Leads, and represents Clinical Regulatory - Rare Diseases to executive leadership and, as needed, the Board, shaping how the organization engages with global Health Authorities and positions itself within an evolving regulatory landscape.