RA CMC Submission Coordinator

Roles & Responsibilities
• Perform Regulatory CMC operational and compliance activities including CMC submission QC checks, document format checks, and IND annual report writing
• Act as CMC regulatory contact for assigned countries and support regulatory database entry and reporting
• Create and manage CMC submission documentation such as folder structures, metadata, and RA request forms
• Ensure CMC documents are eCTD compliant including file naming, PDF property checks, and document formatting
• Coordinate with project teams for document finalization and collection of ancillary documents from multiple sources
• Prepare, track, and coordinate CMC submissions for handover to Regulatory Publishing
• Support KPI tracking and reporting within Regulatory Affairs CMC
• Perform super-user or support super-user activities for RA CMC documentation systems
• Acquire and maintain GMP Certificates and Manufacturing Authorizations in the Document Management System
• Support team members in end-to-end CMC submission coordination

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

Experience
• M.Pharm candidates: Minimum 2 years of experience in Regulatory CMC operations, compliance, and project management
• Other Scientific Master’s degrees: Minimum 3 years of experience in Regulatory CMC operations, compliance, and project management
• Internship experience during degree programs will not be considered

Skills
• Experience with pharmaceutical documentation systems and Regulatory Information Management Systems (RIMS)
• Strong knowledge of regulatory data standards and data management tools
• Ability to work with global, cross-functional teams
• Strong organizational, multitasking, and communication skills
• High digital and data fluency, including exposure to AI-enabled tools and emerging IT technologies

About the Organization
Novartis is a global healthcare company focused on innovative medicines and digital transformation. The organization supports global regulatory and CMC operations through high-quality, compliant, and data-driven processes. Novartis is committed to improving patient access to safe and effective therapies worldwide.