• Support the development and execution of regulatory strategies for assigned programs. • Serve as a key regulatory contributor on cross-functional project teams. • Support interactions with U.S. and global health authorities. • Emphasize hands-on regulatory execution, document preparation, and cross-functional coordination. • Identify and communicate regulatory considerations, risks, and mitigation strategies. • Draft, review, and coordinate regulatory documents for submissions. • Provide regulatory input to CMC teams related to manufacturing changes, comparability, specifications, and lifecycle management. • Act as a regulatory representative on project teams, working closely with Clinical Development and other departments.