Latest Novartis Job Opening | Apply Now for the Submission Coordinator Role
Novartis is hiring an RA CMC Submission Coordinator for its operations in India. This Novartis Job focuses on delivering accurate, compliant, and on-time CMC submissions while maintaining eCTD readiness and managing data within RIMS and DMS. Candidates with a Master’s in Pharmacy and 2+ years of experience, or other scientific Master’s with 3+ years of experience, will lead operational activities, including IND annual report writing, document formatting, and GMP certificate management.
- Job Title: RA CMC Submission Coordinator
- Job ID: REQ-10071286
- Location: India
About The Company
Novartis is a global healthcare leader committed to reimagining medicine to improve and extend people’s lives. The company fosters an inclusive work environment that reflects the diverse communities and patients it serves. Novartis is at the forefront of the digital revolution in healthcare, emphasizing digital and data fluency—including the use of AI-enabled tools—to enhance process efficiency and quality. The organization provides reasonable accommodations for individuals with disabilities, ensuring a supportive recruitment process and workplace.
Summary
Deliver accurate, compliant, and on-time Regulatory CMC operations, compliance, and project management activities, maintaining eCTD readiness, and stewarding data/documents in RIMS/DMS per established procedures. Manage multiple tasks simultaneously, and consistently apply a structured, process-oriented approach. Strong communication skills and a high level of digital and data fluency, including familiarity with AI-enabled tools and emerging IT technologies.
About the Role
Help deliver accurate, compliant, on-time CMC submissions that keep studies moving and products available for patients. This role is ideal for a detail-driven professional who values structured processes and wants to build depth in CMC submission coordination, centralization of regulatory activities, and data and digital tools.
Key Responsibilities
- Perform compliance and operational activities, including CMC submission QC check, Document Format checks, and IND annual report writing. CMC contact for some countries and compliance/regulatory database entry and reports.
- Create CMC submission documentation, such as folder structure, metadata, RA request forms, and act as data stewards in the applicable Regulatory Information and Documentation Management System.
- Ensure CMC documentation is eCTD compliant, eCTD filenames assigned, Document formatting (DA) checked, PDF properties are compliant for eCTD submission, documentation is finalized, and eCTD file names assigned.
- Coordinate data/KPIs required for reports within RA CMC.
- Support project teams for document finalization, collate ancillary documents requirements from various sources (e.g., databases, OneNote, trending, etc.), and support coordination and management through the appropriate system.
- Coordinate, prepare, and track CMC submissions for delivery to RA Publishing.
- Perform the super-user role of RA CMC documentation system/support super-user for e.g,. account requests/ticket generation/modifications as assigned.
- Acquire and maintain GMP Certificates and Manufacturing Authorizations required for RA CMC submission in the Document Management System.
- Support other team members for end-to-end submission coordination.
Essential Requirements
- For Master’s in Pharmacy: Minimum 2 years of regulatory experience in Regulatory CMC operations, compliance, and project management. Internship experience during the degree program is not counted.
- For Other Scientific Master’s Degrees: Minimum 3 years of regulatory experience in Regulatory CMC operations, compliance, and project management. Internship experience during the degree program is not counted.
- Experience with: Pharmaceutical industry documentation systems, Regulatory Information Management Systems (RIMS), Data standards, data systems and data management tools.
- Proven ability to work effectively with global, cross-functional project teams.
- Strong planning, organizational, and interpersonal skills.
- Demonstrated ability to manage multiple priorities simultaneously (multitasking is essential).
- High level of computer literacy and competency with data-driven and IT systems; strong data processing skills.
- High level of digital and data fluency, including familiarity with AI-enabled tools and emerging IT technologies are required for the Novartis Job.
