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Novartis Hiring for RA CMC Submission Coordinator Post
Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
RA CMC Submission Coordinator
REQ-10047824
India
Summary
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 (e.g. 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 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:
- 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
Minimum Requirements:
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 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
- Computer literacy/IT systems literacy: Excellent data processing skills
Skills:
- Being Resilient
- Digital & Technology Savvy
- Continuous Learning
- Interpersonal Savvy
- Operational Excellence
- Project Excellence
Education:
- 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
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