Responsibilities: Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authorities through collaborations with relevant line functions and with minimal supervision....
Responsibilities: Prepare commissioning, qualification, and validation documents for equipment, utilities, and systems. Verify that systems and equipment operate according to design specifications and regulatory requirements. Prepare an...
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 submissio...