RA CMC Senior Submission Coordinator Job at Novartis in Hyderabad for experienced regulatory professionals leading complex global CMC submissions.
Introduction
A senior regulatory affairs opportunity is open for highly experienced professionals specializing in Chemistry, Manufacturing, and Controls (CMC) submissions. The RA CMC Senior Submission Coordinator role is designed for candidates who can independently manage complex global submissions, ensure regulatory compliance, and lead cross-functional coordination activities. This position offers long-term career growth for professionals seeking ownership of end-to-end CMC regulatory operations within a global pharmaceutical environment. RA CMC Senior Submission Coordinator Job
Company Overview
Novartis is a science-led healthcare organization focused on discovering new ways to improve and extend human life. With a strong global footprint and a commitment to innovation, Novartis delivers high-quality medicines through rigorous regulatory standards, digital transformation, and data-driven regulatory strategies. The organization strongly promotes diversity, inclusion, and accessibility across its global workforce. RA CMC Senior Submission Coordinator Job
Job Location & Employment Type
- Job Location: Hyderabad, Telangana, India
- Employment Type: Full-time
- Work Mode: Office-based
- Job Requisition ID: REQ-10071289
Open Positions / Department Details
- Job Title: RA CMC Senior Submission Coordinator
- Department: Regulatory Affairs – CMC
- Career Level: Senior / Lead Regulatory Professional
This role involves independent leadership of CMC submission coordination and regulatory compliance activities across the product lifecycle.
Key Roles & Responsibilities
CMC Submission Leadership & Compliance
The selected professional will independently manage complex CMC submission activities while ensuring high-quality and compliant regulatory deliverables. RA CMC Senior Submission Coordinator Job
Key responsibilities include:
- Independently performing RA CMC compliance and operational activities, including quality checks, document authoring checks, and IND Annual Report coordination
- Acting as the primary CMC regulatory contact for assigned countries
- Managing compliance and regulatory database entries and reports
- Ensuring correct eCTD operator attributes, module structures, and chapter assignments
Submission Documentation & Regulatory Systems
- Creating and maintaining CMC submission documentation such as folder structures, metadata forms, regulatory request forms, tracking sheets, letters, and health authority forms
- Acting as a super-user, business data owner, and data steward within Regulatory Information Management Systems (RIMS)
- Proactively ensuring all CMC documents are eCTD compliant and submission-ready
- Maintaining eCTD compliance for internal and third-party documentation linked to CMC modules
Project Coordination & Global Collaboration
- Independently supporting CMC project teams during document finalization and source document management
- Coordinating ancillary document collection and submission compilation
- Preparing, compiling, and tracking CMC submissions for handover to Regulatory Operations or Publishing teams
- Managing Country Organization requests through RA CMC ticketing systems
- Organizing submission coordination activities across multiple global stakeholders
RA CMC Senior Submission Coordinator Job
Advanced Regulatory Operations & Leadership
- Acting as a key member of global RA CMC project teams by contributing to operational and compliance strategies
- Identifying potential compliance risks and sharing best practices and lessons learned
- Acquiring and maintaining GMP certificates and manufacturing authorizations within document management systems
- Coordinating preparation of regulatory declarations required for Rest of World (RoW) submissions
- Supporting departmental initiatives related to regulatory operations, compliance excellence, and Data & Digital transformation
- Mentoring and supporting team members in advanced submission coordination activities
RA CMC Senior Submission Coordinator Job
Eligibility Criteria
Education
Candidates must hold 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 5 years of hands-on experience in Regulatory CMC operations, compliance, and submission project management
- For other scientific master’s degrees: Minimum 6 years of relevant regulatory CMC experience
- Internship or academic experience is not counted toward the required experience
Skills Required
- Advanced expertise in Regulatory CMC submission workflows
- Strong experience in regulatory project management
- Hands-on knowledge of pharmaceutical documentation systems
- Proficiency with Regulatory Information Management Systems (RIMS)
- Strong understanding of data standards, regulatory databases, and digital regulatory tools
- Proven ability to independently manage multiple complex priorities
- Excellent planning, organizational, and stakeholder management skills
- High level of computer literacy and data-processing capability
- Strong digital fluency, including exposure to AI-enabled tools and emerging IT technologies
- Ability to collaborate effectively with global, cross-functional teams
RA CMC Senior Submission Coordinator Job
Salary & Benefits
- Salary: As per company norms
Additional benefits may include:
- Permanent full-time employment
- Leadership role in global regulatory CMC operations
- Exposure to high-impact, complex regulatory submissions
- Opportunity to contribute to data and digital regulatory initiatives
- Inclusive, diverse, and accessibility-focused workplace
- Long-term career advancement within regulatory affairs leadership tracks
Selection Process
The selection process may include:
- Application screening
- Senior-level technical and leadership interviews
- HR and final discussion
Only shortlisted candidates will be contacted by the employer.
How to Apply
- Mode of Application: Online Application
Eligible candidates should apply through the official application portal provided by the employer.
Important Dates
- Last Date to Apply: February 23, 2026
Applicants are encouraged to apply well in advance of the deadline.
Why Apply for This Pharma Job?
This role is ideal for senior regulatory professionals seeking autonomy, leadership, and strategic involvement in global CMC submissions. With responsibility for complex regulatory coordination, digital systems, and compliance strategy, candidates can significantly strengthen their expertise and influence within regulatory affairs while working in a globally respected pharmaceutical organization. RA CMC Senior Submission Coordinator Job
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform and is not affiliated with Novartis or any organization. Job information is provided strictly for reference purposes. Candidates should verify details through official employer communication before applying. RA CMC Senior Submission Coordinator Job
Final Call-to-Action
If you have strong experience in Regulatory CMC submissions and are ready to lead complex global regulatory operations, apply now to advance your career. RA CMC Senior Submission Coordinator Job
