Summary

Provide advanced regulatory CMC operational, submission and compliance support to department in accordance with 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:

• Independently, perform RA CMC compliance and operational support including QC check, DA checks, IND AR writing & coordination. CMC contact for some countries, compliance/regulatory database entry and reports and ensure appropriate eCTD operator attributes, module chapters
• Create CMC submission documentation such as folders structure, metadata forms, RA request forms, populating RA CMC tracking sheets, letters, and various Health Authority forms. Act as super-user, business data owner and data steward in the applicable Regulatory Information Management System
• Proactively ensure CMC documentation is eCTD compliant and submission ready. Support eCTD compliance maintenance for the external documentation linked to the CMC submission modules, including third party documentation
• Independently support CMC project teams for document finalization, ancillary documents coordination and source documents management. Coordinate, prepare, compile and track CMC submissions for delivery to RA Operations
• Support RA CMC project teams to handle Country Organization (CO) request in the RA CMC ticketing system, organizing submission coordination activities like source documents and ancillary documents collection
• Perform super-user role of documentation system / support super-user for e.g. account requests / modifications as assigned
• Actively participate as a member of the global RA CMC project teams by contributing to the project operational and compliance strategy, identifying the potential compliance issues and sharing lessons learned
• Acquire and maintain GMP Certificates and Manufacturing Authorizations required for RA CMC submission in the Document Management System
• Coordinate preparation of declarations required for submission in RoW countries
• Support other GSOC team members in leading various operations, compliance, Data & Digital initiatives

• 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
• Proactive and accurate information / communication about operational and compliance issues within own department and to key stakeholders
• Independently 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 stakeholders
• Partner with other GSOC team members to ensure business continuity

• Preferably 3 years in regulatory submission management.
• Working experience in pharma industry data systems, data and submission management
• Ability to work successfully with global project teams and prioritize activities considering timelines and workload
• Effective planning, organizational and interpersonal skills
• Prior submission management/publishing experience desired
• Computer literacy/IT systems literacy: Excellent data processing skills with current operating systems

• Documentation Management.
• Project Excellence
• Digital & Data savvy
• Interpersonal Skills
• Operational Excellence.
• Regulatory Compliance.

• English.