Regulatory Affairs Manager CMC

Job Title

Responsibilities : Support preparation, review, and submission of CMC sections for U.S and global regulatory filings (INDs / CTAs, amendments, and BLAs / MAAs). Coordinate with internal stakeholders to gather technical information and ensure accuracy and consistency across CMC documentation. Assist in developing and maintaining submission plans for assigned programs. Review and provide feedback on CMC sections of regulatory documents, ensuring compliance with regulatory requirements and internal standards. Participate in cross-functional teams to support CMC activities and contribute to project timelines and deliverables.