Partner closely with Regulatory CMC Program Leads and cross-functional subject matter experts to plan, prepare, review, and coordinate CMC components of global regulatory submissions, including INDs, CTAs, BLAs, MAAs, amendments, supplements, and responses to Health Authority requests. Evaluate and interpret technical documentation, including development reports, validation protocols and reports, comparability assessments, and manufacturing change packages, to support regulatory impact assessments, submission strategies, and regulatory decision-making.