Job description
Provide regulatory CMC operational, submission and compliance support to department in accordance to defined requirements to guarantee timely preparation of high-quality CMC regulatory submissions and associated compliance information throughout the life cycle.
About the Role
Major accountabilities:
- Perform compliance and operational activities including QC check, DA checks and IND annual report writing. CMC contact for some countries and compliance/ regulatory database entry and reports
- Create CMC submission documentation such as folders structure, metadata forms, RA request forms and act as data stewards in the applicable Regulatory Information Management System
- Ensure CMC documentation is eCTD compliant, eCTD filenames assigned, Document formatting (DA) checked, PDF properties are compliant for eCTD submission, documentation is finalized and eCTD file names assigned
- Coordinate data/KPIs required for reports within RA CMC
- Support project teams for document finalization, collate ancillary documents requirements from various sources (eg databases, OneNote, trending etc) and support coordination and management through the appropriate system
- Coordinate, prepare and track CMC submissions for delivery to RA Operations
- Perform super-user role of RA CMC documentation system/ support super-user for eg account requests/ modifications as assigned
- Acquire and maintain GMP Certificates and Manufacturing Authorizations required for RA CMC submission in the Document Management System
- Support other GSOC team members for end-to-end submission coordination
Key performance indicators:
- High quality regulatory submissions and operational documentation
- Timeliness of deliverables: No delays in approvals of clinical studies, global registration dossiers or variations due to late or inadequate CMC documentation and compliance support on matters within RA CMC control
- Timely and accurate information / communication about operational and compliance issues within own department and to key stakeholders
- Ensure that the operational activities and CMC regulatory documentation follow Novartis and eCTD guidelines. Regulatory compliance met in all compliance systems
- Build and maintain collaborative partnerships with stakeholder
- Partner with other GSOC team members to ensure business continuity
Work Experience:
- If University entrance or completed vocational training: Preferably 2 years in regulatory and/or experience in the pharmaceutical industry
- If Science Degree: Preferably 1 year in regulatory a
