RA CMC Submission Coordinator Job in Hyderabad at Novartis for experienced regulatory professionals with eCTD, RIMS, and global submission exposure.
Introduction
A senior-level regulatory affairs opportunity is open for experienced professionals specializing in Chemistry, Manufacturing, and Controls (CMC) submissions. This RA CMC Submission Coordinator role is ideal for candidates who thrive in structured, compliance-driven environments and want to deepen their expertise in global regulatory submissions, eCTD readiness, and regulatory data systems. The position offers exposure to end-to-end CMC submission coordination within a globally regulated pharmaceutical organization. RA CMC Submission Coordinator Job
Company Overview
Novartis is a leading global healthcare organization focused on reimagining medicine to improve and extend people’s lives. The company operates across pharmaceuticals and innovative therapies, supporting patients worldwide through science-driven research and high regulatory standards. Novartis promotes an inclusive work culture, embraces digital transformation, and continuously invests in advanced regulatory, data, and compliance capabilities across its global operations. RA CMC Submission Coordinator Job
Job Location & Employment Type
- Job Location: Hyderabad, Telangana, India
- Employment Type: Full-time
- Work Mode: Office-based
- Job Requisition ID: REQ-10071286
Open Positions / Department Details
- Job Title: RA CMC Submission Coordinator
- Department: Regulatory Affairs – CMC
- Career Level: Experienced Professional
- Reporting Function: Regulatory CMC Operations
This role supports centralized regulatory CMC activities, compliance operations, and submission coordination across global projects. RA CMC Submission Coordinator Job
Key Roles & Responsibilities
Regulatory CMC Operations & Compliance
The selected candidate will play a key role in ensuring accurate, compliant, and timely CMC submissions.
Key responsibilities include:
- Performing regulatory compliance activities including CMC submission quality checks
- Conducting document format and technical compliance checks for regulatory submissions
- Supporting preparation of IND Annual Reports related to CMC activities
- Acting as CMC regulatory contact for assigned countries
- Managing regulatory database entries and generating compliance reports
Submission Documentation & eCTD Readiness
- Creating and maintaining CMC submission folder structures and metadata
- Preparing regulatory request forms and managing documentation workflows
- Ensuring CMC documents meet eCTD technical requirements
- Verifying eCTD-compliant file naming conventions and PDF properties
- Performing document formatting and document authoring checks
- Finalizing documentation prior to submission handover
Regulatory Systems & Data Stewardship
- Acting as a data steward within Regulatory Information Management Systems (RIMS) and Document Management Systems (DMS)
- Coordinating data and KPI inputs for RA CMC reporting
- Supporting project teams during document finalization and submission preparation
- Collating ancillary documents from multiple internal systems and data sources
- Coordinating and tracking CMC submissions through Regulatory Publishing teams
RA CMC Submission Coordinator Job
System Support & Cross-Functional Collaboration
- Serving as a super-user or supporting super-user activities for RA CMC documentation systems
- Handling system access requests, ticket creation, and system modifications
- Maintaining GMP certificates and manufacturing authorizations within document repositories
- Supporting team members with end-to-end CMC submission coordination
- Collaborating with global, cross-functional project teams to resolve submission-related issues
RA CMC Submission Coordinator Job
Eligibility Criteria
Education
Candidates must possess one of the following qualifications:
- Master’s degree in Pharmacy (M.Pharm)
- Master’s degree in a relevant scientific discipline
Experience
- For M.Pharm candidates: Minimum 2 years of hands-on experience in Regulatory CMC operations, compliance, or submission coordination
- For other scientific master’s degrees: Minimum 3 years of relevant regulatory CMC experience
- Internship or academic project experience is not counted toward required experience
Skills Required
- Strong working knowledge of Regulatory CMC processes and submission workflows
- Hands-on experience with Regulatory Information Management Systems (RIMS)
- Experience with pharmaceutical documentation and data management systems
- Understanding of data standards, regulatory databases, and compliance reporting
- Excellent planning, organization, and time-management skills
- Ability to manage multiple priorities in parallel
- Strong communication and stakeholder coordination skills
- High level of computer literacy and data-handling capability
- Digital and data fluency, including exposure to AI-enabled tools and emerging IT technologies
RA CMC Submission Coordinator Job
Salary & Benefits
- Salary: As per company norms
Additional benefits may include:
- Full-time permanent employment
- Exposure to global regulatory CMC operations
- Opportunity to work on complex regulatory submissions
- Skill development in eCTD, RIMS, and digital regulatory tools
- Inclusive and diverse workplace culture
- Career progression within regulatory affairs and compliance functions
Selection Process
The selection process may include:
- Application screening
- Technical interview with Regulatory CMC team
- HR and final discussion
Only shortlisted candidates will be contacted by the employer.
How to Apply
- Mode of Application: Online Application
Interested and eligible candidates should apply through the official application portal provided by the employer. RA CMC Submission Coordinator Job
Important Dates
- Last Date to Apply: February 23, 2026
Candidates are encouraged to apply well before the deadline.
Why Apply for This Pharma Job?
This role offers a strong opportunity for regulatory professionals to build long-term expertise in CMC submissions, regulatory systems, and compliance operations. With exposure to global regulatory frameworks, advanced digital tools, and structured submission processes, candidates can significantly strengthen their regulatory career while working in a high-impact environment. RA CMC Submission Coordinator Job
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform and is not affiliated with Novartis or any organization. Job details are shared for informational purposes only. Candidates should verify all information through official employer communication before applying. RA CMC Submission Coordinator Job
Final Call-to-Action
If you have experience in Regulatory CMC operations and are ready to take ownership of complex submission activities, apply now and advance your regulatory affairs career. RA CMC Submission Coordinator Job
