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RA CMC Senior Submission Coordinator
3-7 years
Hyderabad / Secunderabad
1 vacancy
RA CMC Senior Submission Coordinator
Novartis
posted 10d ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
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
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
- 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
Minimum Requirements:
Work Experience:
Work Experience:
- 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
Skills:
- Documentation Management.
- Project Excellence
- Digital & Data savvy
- Interpersonal Skills
- Operational Excellence.
- Regulatory Compliance.
Languages:
- English.
Employment Type: Full Time, Permanent
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Coordinator salary at Novartis
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4
employees
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What Novartis employees are saying about work life
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Flexible timing
Monday to Friday
No travel
Day Shift
Novartis Benefits
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