Ra Cmc Submission Coordinator

7 days ago


Hyderabad Telangana, India Novartis Full time

**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

Division

Development

Business Unit

Innovative Medicines

Location

India

Site

Hyderabad (Office)

Company / Legal Entity

IN10 (FCRS = IN010) Novartis Healthcare Private Limited

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

No

**Accessibility and accommodation**:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.


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