li>Accountable for ensuring global CMC content quality and compliance for early development submissions and lifecycle changes through Phase 2 (e.g., IND/CTA modules, IMPD quality sections, amendments, investigatorās brochure CMC, and responses to health authority questions), partnering with regional leads and technical functions to ensure consistent, inspection-ready documentation. Represents Global Regulatory Affairs CMC in senior-level governance and in interactions with global health authorities, including FDA, EMA, MHRA, PMDA, and other agencies as applicable, to enable efficient pathways for early development CMC strategies and submissions (e.g., pre-IND/IND/CTA, amendments, Type B/C meetings, scientific advice).