Katalyst Healthcares & Life Sciences
CMCRegulatoryAffairsManager
Katalyst Healthcares & Life Sciences, Tarrytown, New York, United States, 10591
Job Title
Responsibilities: Lead the preparation, review, and submission of CMC sections of regulatory filings (e.g., INDs, NDAs, BLAs, MAAs, variations, renewals) to global health authorities, ensuring accuracy, completeness, and compliance with applicable regulations and guidelines. Provide regulatory guidance and support to cross-functional teams throughout the product development lifecycle, including but not limited to CMC strategy development, regulatory submissions, and post-approval changes.
Responsibilities: Lead the preparation, review, and submission of CMC sections of regulatory filings (e.g., INDs, NDAs, BLAs, MAAs, variations, renewals) to global health authorities, ensuring accuracy, completeness, and compliance with applicable regulations and guidelines. Provide regulatory guidance and support to cross-functional teams throughout the product development lifecycle, including but not limited to CMC strategy development, regulatory submissions, and post-approval changes.