Pharma Job: Novartis hiring Research Associate CMC Submission Coordinator – Apply Now
Are you a detail-oriented and organized professional with 2+ years of experience in regulatory affairs or the pharmaceutical industry? Novartis, a leading pharmaceutical company dedicated to making a positive impact on global health, is seeking a dedicated RA CMC Submission Coordinator to join our team in India. If you have a strong focus on compliance, operational efficiency, and a passion for supporting the timely preparation of high-quality CMC regulatory submissions, we encourage you to apply!
Job ID: REQ-10047824
Date: Apr 09, 2025
Location: India
About the Role:
Major accountabilities:
As an RA CMC Submission Coordinator at Novartis, your primary accountabilities will include:
- Performing compliance and operational activities, including QC checks, DA checks, and IND annual report writing.
- Creating CMC submission documentation, such as folder structure, metadata forms, and RA request forms.
- Coordinating, preparing, and tracking CMC submissions for delivery to RA Operations.
- Support other GSOC team members in 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.
Minimum Requirements of a Research Associate :
- Work Experience: 2 years in regulatory and/or experience in the pharmaceutical industry for University entrance or completed vocational training.
- Skills: Being resilient, digital & technology savvy, continuous learning, and interpersonal savvy.
- Education: General qualification for university entrance or completed vocational training.
- Languages: Fluent English required
Keywords: Novartis, pharmaceutical industry, regulatory compliance, CMC submission, operational coordination, global health, Pharma Novartis Research Associate
