RA CMC Senior Submission Coordinator

Roles & Responsibilities
• Independently manage end-to-end coordination of complex CMC submissions
• Perform RA CMC compliance activities including QC checks, DA checks, and IND Annual Report coordination
• Act as CMC regulatory contact for assigned countries and manage regulatory database entries
• Create and manage CMC submission documents, metadata, tracking sheets, and Health Authority forms
• Ensure CMC documentation is eCTD compliant and submission-ready
• Coordinate document finalization, ancillary documents, and submission delivery to RA Operations
• Support global RA CMC project teams, ticketing systems, and compliance initiatives
• Maintain GMP Certificates and Manufacturing Authorizations in DMS

Qualification
• Master’s in Pharmacy or other Scientific Master’s Degree

Experience
• M.Pharm: Minimum 5 years in Regulatory CMC operations
• Other Master’s: Minimum 6 years in Regulatory CMC operations

Skills
• Regulatory CMC project management and submission coordination
• RIMS and pharmaceutical documentation systems
• Strong organizational, communication, and multitasking skills
• High digital and data fluency, including AI-enabled tools

About the Organization
Novartis is a global healthcare company delivering innovative medicines and regulatory excellence. The organization supports high-quality CMC and regulatory operations across global markets. Novartis is committed to diversity, inclusion, and improving patient outcomes worldwide.