Join Novartis as an RA CMC Submission Coordinator – Drive Regulatory Excellence

 RA CMC Submission Coordinator – at Novartis, Apply Now!

Are you detail-oriented with a passion for regulatory affairs in the pharmaceutical industry? The RA CMC Submission Coordinator role at Novartis offers a unique opportunity to contribute to high-quality regulatory submissions, compliance, and data integrity. Based on your scientific expertise, you’ll support the regulatory lifecycle of breakthrough therapies. If you’re ready to thrive in a global team and shape the future of medicine, this position in regulatory CMC could be the next big step in your career.

Job Title: RA CMC Submission Coordinator

Job ID: REQ-10047824

Summary

Provide regulatory CMC operational, submission, and compliance support to the department in accordance with defined requirements to guarantee timely preparation of high-quality CMC regulatory submissions and associated compliance information throughout the lifecycle.

Major accountabilities for Submission Coordinator:

• 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 (e.g. databases, OneNote, trending etc.) and support coordination and management through the appropriate system as Submission Coordinator
• Coordinate, prepare and track CMC submissions for delivery to RA Operations
• Perform super-user role of RA CMC documentation system/ support super-user for e.g. 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 for Submission Coordinator:

• 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 preferred for Submission Coordinator
• Partner with other GSOC team members to ensure business continuity ​

Minimum Requirements:

Work Experience for Submission Coordinator:

• 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 and/or experience in the pharmaceutical industry
• Working experience in pharma industry data systems and data management
• Ability to work successfully with global project teams and prioritize activities considering timelines and workload
• Effective planning, organizational and interpersonal skills
• Prior publishing experience desired as Submission Coordinator
• Computer literacy/IT systems literacy: Excellent data processing skills

Skills:

• Being Resilient
• Digital & Technology Savvy
• Continuous Learning
• Interpersonal Savvy
• Operational Excellence
•  Project Excellence

Education for Submission Coordinator:

• Minimum: General qualification for university entrance or completed vocational training
• Desirable: Science Degree (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent

Languages:

• Fluent English required (oral and written). Good written/spoken communication skills

APPLY ONLINE HERE

Keywords: RA CMC Submission Coordinator, Novartis job, pharmaceutical industry, regulatory compliance, data management