Katalyst Healthcares & Life Sciences
Global Regulatory CMC Manager
Katalyst Healthcares & Life Sciences, Lawrence Township, New Jersey, United States, 08648
CMC Regulatory Strategy Development
Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules. These submissions include health authority briefing packages, IND/CTA, NDA, and MAA regulatory filings. Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authorities through collaborations with r...
Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules. These submissions include health authority briefing packages, IND/CTA, NDA, and MAA regulatory filings. Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authorities through collaborations with r...