Novartis is inviting applications for the position of RA CMC Submission Coordinator at its Hyderabad office. This Regulatory CMC job in Hyderabad is ideal for professionals with hands-on experience in Regulatory CMC operations, eCTD submissions, RIMS systems, and regulatory compliance within the pharmaceutical industry.
If you have experience in CMC submission coordination, regulatory documentation management, IND annual report writing, and data stewardship, this opportunity offers structured exposure to global regulatory frameworks and digital regulatory systems.
Job Overview
- Position: RA CMC Submission Coordinator
- Company: Novartis
- Location: Hyderabad (Office-based)
- Job Type: Full-Time
- Job Requisition ID: REQ-10071286
- Application Deadline: February 25, 2026
This Regulatory Affairs CMC role focuses on delivering accurate, compliant, and on-time CMC submissions, ensuring eCTD readiness and maintaining regulatory documentation in RIMS/DMS systems.
Key Responsibilities – RA CMC Submission Coordinator
The selected candidate will be responsible for:
Regulatory CMC Operations
- Perform CMC submission QC checks
- Conduct document formatting and eCTD compliance checks
- Assign eCTD file names and validate PDF properties
- Support IND annual report writing
Submission & Documentation Management
- Create folder structures and metadata for CMC submissions
- Maintain data stewardship in Regulatory Information & Documentation Management Systems (RIMS/DMS)
- Coordinate, prepare, and track CMC submissions for RA Publishing
- Acquire and maintain GMP Certificates and Manufacturing Authorizations
Compliance & Data Management
- Ensure documentation compliance with regulatory standards
- Enter regulatory database data and generate compliance reports
- Support KPI data collation and reporting
- Act as super-user/support user for RA CMC documentation systems
Cross-Functional Coordination
- Work with global, cross-functional project teams
- Support document finalization and ancillary documentation collection
- Manage multiple regulatory priorities simultaneously
Eligibility & Qualifications
Educational Requirements
- Master’s in Pharmacy – Minimum 2 years regulatory CMC experience
OR - Other Scientific Master’s Degree – Minimum 3 years regulatory CMC experience
(Internship experience is not counted.)
Required Experience & Skills
- Experience in Regulatory CMC operations and compliance
- Familiarity with RIMS, DMS, eCTD structure, and pharmaceutical documentation systems
- Knowledge of data standards and data management tools
- Strong planning, analytical, and organizational skills
- High digital fluency, including exposure to AI-enabled tools and emerging IT technologies
- Ability to multitask in a structured regulatory environment
Why Join Novartis?
Working with Novartis in this Regulatory Affairs CMC job offers:
- Exposure to global CMC submission frameworks
- Structured regulatory project management experience
- Hands-on work with eCTD and RIMS systems
- Opportunities to build expertise in regulatory data and digital tools
- Inclusive, diverse, and global work culture
Novartis is committed to diversity, inclusion, and providing reasonable accommodation to individuals with disabilities.
How to Apply
