Job Title: RA CMC Submission Coordinator
Job ID: REQ-10047824
Location: India
Job Description
Novartis is seeking a Regulatory Affairs (RA) CMC Submission Coordinator to provide operational, submission, and compliance support for high-quality Chemistry, Manufacturing, and Controls (CMC) regulatory submissions. This role ensures timely preparation and compliance of CMC documentation throughout the product lifecycle.
Key Responsibilities:
- Perform compliance and operational activities, including QC checks, Document Accuracy (DA) checks, and IND annual report writing.
- Act as the CMC contact for select countries, ensuring regulatory database entries and reports are up to date.
- Create CMC submission documentation, including folder structures, metadata forms, and RA request forms.
- Ensure all CMC documentation is eCTD compliant, with proper file naming, formatting, and PDF properties.
- Coordinate data/KPIs for regulatory reports and support project teams in finalizing documentation.
- Track and prepare CMC submissions for delivery to RA Operations.
- Serve as a super-user for RA CMC documentation systems, managing account requests and modifications.
- Acquire and maintain GMP Certificates and Manufacturing Authorizations in the Document Management System.
- Support Global Submission Operations Center (GSOC) team members in end-to-end submission coordination.
Key Performance Indicators (KPIs):
- High-quality regulatory submissions with no delays in approvals.
- Timely and accurate communication of operational and compliance issues.
- Regulatory compliance in all documentation and systems.
- Strong collaboration with stakeholders and business continuity support.
About Novartis
Novartis is a global healthcare leader focused on innovative medicines, generics, and biosimilars. With a mission to reimagine medicine, Novartis is committed to improving patient outcomes through cutting-edge research and regulatory excellence.
Eligibility Criteria
Minimum Requirements:
- Education:
- Minimum: University entrance qualification or completed vocational training.
- Preferred: Science degree (Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology).
- Experience:
- University/vocational background: 2+ years in regulatory affairs or pharmaceutical industry.
- Science degree holders: 1+ year in regulatory affairs or pharmaceutical industry.
- Skills:
- Experience in pharma data systems and management.
- Strong planning, organizational, and interpersonal skills.
- Publishing experience (preferred).
- Tech-savvy with excellent data processing skills.
Desired Competencies:
- Being Resilient
- Digital & Technology Savvy
- Continuous Learning
- Interpersonal Savvy
- Operational Excellence
- Project Excellence
