RA CMC Submission Coordinator Job at Novartis in Hyderabad. Regulatory Affairs CMC role. Apply before 6 March 2026.
Regulatory Affairs professionals with expertise in CMC documentation and submission coordination have an excellent career opportunity in Hyderabad. A full-time opening is available for an experienced RA CMC Submission Coordinator who can manage compliance-driven submission processes, maintain eCTD readiness, and ensure structured regulatory documentation management. This role is ideal for candidates seeking to strengthen their career in Regulatory CMC operations within a global pharmaceutical environment. RA CMC Submission Coordinator Job at Novartis
Company Overview
Novartis is a leading global healthcare organization focused on innovative medicines that address serious diseases. With a strong presence in India and worldwide operations, the company emphasizes regulatory excellence, patient-centric development, and digital transformation in pharmaceutical processes. Regulatory Affairs plays a critical role in ensuring timely approvals, compliance, and seamless product lifecycle management. RA CMC Submission Coordinator Job at Novartis
Job Location & Employment Type
- Location: Hyderabad (Office-based role)
- Employment Type: Full-Time
- Department: Regulatory Affairs – CMC
Position Details
Job Title: RA CMC Submission Coordinator
Job Requisition ID: REQ-10071286
Application Deadline: 6 March 2026
Posted On: Recently
This role focuses on delivering accurate, compliant, and timely Chemistry, Manufacturing & Controls (CMC) submission operations. The position supports structured regulatory processes, documentation oversight, and digital system management to maintain high regulatory standards. RA CMC Submission Coordinator Job at Novartis
Key Roles & Responsibilities
The RA CMC Submission Coordinator will contribute to regulatory compliance and documentation excellence through the following responsibilities:
- Conduct quality control checks for CMC submission documents
- Perform document formatting reviews and ensure compliance with regulatory submission standards
- Prepare and support IND Annual Reports
- Serve as CMC contact for assigned countries and manage regulatory database entries
- Develop CMC submission folder structures, assign metadata, and prepare Regulatory Affairs request forms
- Act as a data steward within Regulatory Information Management Systems (RIMS) and Document Management Systems (DMS)
- Ensure documentation is compliant with eCTD standards, including correct file naming conventions and PDF property validation
- Coordinate collection and compilation of ancillary regulatory documents from various data sources
- Track and manage submission timelines and coordinate with RA Publishing teams
- Support KPI reporting activities within RA CMC operations
- Perform super-user responsibilities for RA CMC documentation systems (account management, issue tracking, and ticket handling)
- Maintain GMP Certificates and Manufacturing Authorizations within document management systems
- Assist team members with end-to-end submission coordination
The role requires structured thinking, attention to detail, and the ability to manage multiple submission activities simultaneously. RA CMC Submission Coordinator Job at Novartis
Eligibility Criteria
Education
- Master’s degree in Pharmacy with a minimum of 2 years of regulatory experience in CMC operations
OR - Master’s degree in other scientific disciplines (e.g., Life Sciences) with a minimum of 3 years of regulatory CMC experience
Note: Internship experience during academic programs will not be considered as qualifying experience. RA CMC Submission Coordinator Job at Novartis
Experience
- Experience in Regulatory CMC operations, compliance activities, and submission project coordination
- Hands-on exposure to pharmaceutical documentation systems
- Working knowledge of Regulatory Information Management Systems (RIMS)
- Familiarity with data standards, regulatory databases, and document management systems
- Experience working with global cross-functional teams
Skills Required
- Strong analytical and detail-oriented approach
- Thorough understanding of regulatory compliance and documentation standards
- Ability to manage multiple priorities and deadlines effectively
- Strong organizational and project coordination skills
- High level of digital proficiency and comfort with data-driven systems
- Familiarity with AI-enabled tools and emerging digital technologies
- Excellent communication and interpersonal skills
- Capability to work collaboratively within global regulatory teams
Salary & Benefits
Compensation and benefits will be offered as per company norms and in alignment with candidate experience and organizational policies. RA CMC Submission Coordinator Job at Novartis
Selection Process
The hiring process may include:
- Initial screening of applications
- Technical evaluation focused on Regulatory CMC knowledge
- Interview rounds with regulatory and hiring teams
- Final selection and offer issuance
Candidates meeting eligibility criteria will be contacted directly for further recruitment steps. RA CMC Submission Coordinator Job at Novartis
How to Apply
Eligible and interested candidates must apply online through the official company application portal before 6 March 2026. Applicants should ensure their CV clearly highlights CMC submission experience, regulatory system exposure, and project coordination capabilities. RA CMC Submission Coordinator Job at Novartis
Important Dates
- Application Deadline: 6 March 2026
- Limited time remaining to apply
Candidates are encouraged to complete their application at the earliest to avoid missing the deadline.
Why Apply for This Pharma Job?
Regulatory CMC professionals are in high demand as pharmaceutical companies continue to expand global product registrations and lifecycle management activities. This opportunity offers:
- Direct involvement in CMC submission coordination and compliance activities
- Exposure to global regulatory systems and digital transformation initiatives
- Development of expertise in eCTD readiness and regulatory documentation management
- Opportunity to work in a structured, compliance-focused environment
- Career progression within Regulatory Affairs operations
Professionals seeking long-term growth in Regulatory Affairs CMC operations, submission coordination, and digital regulatory systems will find this role highly valuable. RA CMC Submission Coordinator Job at Novartis
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform providing pharmaceutical and healthcare job updates for informational purposes only. We are not affiliated with Novartis or any other organization mentioned above. Applicants are advised to verify complete job details through the official company website before applying. RA CMC Submission Coordinator Job at Novartis
Interested candidates with relevant Regulatory CMC experience should submit their online application before the closing date to advance their career in global regulatory operations. RA CMC Submission Coordinator Job at Novartis
