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RA CMC Senior Submission Coordinator
Sandoz
posted 1mon ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Job Description
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.
Skills Desired
Clinical Study Reports, Data Analysis, Documentation Management, Lifesciences, Operational Excellence, Regulatory ComplianceEmployment Type: Full Time, Permanent
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What people at Sandoz are saying
Rating based on 1 Coordinator
review
Anonymous · Healthcare & Life Sciences - Other
in Hyderabad
Likes
Having learning time.
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Read 1 reviewCoordinator salary at Sandoz
reported by
1
employee
with 7
years exp.
₹9.9
L/yr - ₹12.7
L/yr
247%
more
than the average Coordinator Salary in India
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What Sandoz employees are saying about work life
based on 388 employees
Flexible timing
Monday to Friday
No travel
Day Shift
Sandoz Benefits
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Competitive compensation Pay equity Pay for sustainable performance Differentiated benefits and wellbeing programs Values & integrity Balanced rewards
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