Novartis Hiring RA CMC Submission Coordinator Job in Hyderabad. Regulatory affairs role with urgent deadline. Apply before Feb 25 now.
Company Overview
Novartis is a globally recognized pharmaceutical organization focused on reimagining medicine to improve and extend people’s lives. With a strong footprint in innovative therapies, generics, and advanced research, Novartis operates across multiple countries and therapeutic areas. The company is known for its cutting-edge regulatory frameworks, digital transformation initiatives, and patient-centric innovation. In India, Novartis offers diverse opportunities for professionals in regulatory affairs, clinical development, and global drug lifecycle management.
Job Location & Employment Type
- Location: Hyderabad, India (Office-Based Role)
- Employment Type: Full-Time
- Department: Regulatory Affairs – CMC
- Job Requisition ID: REQ-10071286
Open Positions / Department Details
- Role: RA CMC Submission Coordinator
- Function: Regulatory Affairs – Chemistry, Manufacturing & Controls (CMC)
This role is designed for professionals experienced in regulatory CMC operations and documentation coordination within global pharmaceutical environments.
Key Roles & Responsibilities
The selected candidate will support global regulatory submission workflows and ensure accuracy, compliance, and timeliness of CMC submissions.
Core Responsibilities
- Perform quality checks on CMC submission documents and ensure regulatory compliance.
- Review formatting and technical aspects of submission-ready documentation.
- Prepare documentation structures and metadata aligned with regulatory submission standards.
- Maintain regulatory data and documents within RIMS and DMS platforms.
- Ensure eCTD compliance including file naming, formatting validation, and submission readiness.
- Support preparation of regulatory reports and annual submission documentation.
- Coordinate with internal stakeholders to collect and finalize submission components.
- Track CMC submission timelines and coordinate delivery to publishing teams.
- Support documentation system administration or super-user responsibilities.
- Maintain GMP certificates and manufacturing authorizations for regulatory filings.
- Assist cross-functional teams in end-to-end submission coordination activities.
This role requires strong attention to detail and a structured, process-driven mindset.
Eligibility Criteria
Education
- Master’s degree in Pharmacy (preferred)
OR - Master’s degree in Life Sciences or related scientific disciplines.
Experience
- M.Pharm candidates: Minimum 2 years of regulatory CMC experience.
- Other scientific postgraduates: Minimum 3 years of regulatory experience.
- Internship experience during academic programs is not counted.
Skills Required
Regulatory & Technical Skills
- Experience in Regulatory CMC documentation and submission processes.
- Hands-on exposure to RIMS, DMS, and regulatory data systems.
- Understanding of eCTD submission formats and documentation standards.
- Knowledge of pharmaceutical regulatory workflows and compliance frameworks.
- Experience working with structured data and submission tools.
Digital & Analytical Skills
- Strong digital fluency with modern IT tools and data-driven workflows.
- Familiarity with emerging technologies including AI-enabled regulatory tools.
- Ability to manage structured data and generate insights from documentation systems.
Functional Skills
- Excellent planning and organizational abilities.
- Strong multitasking capability with ability to manage multiple submissions.
- Good interpersonal skills for cross-functional collaboration.
- High attention to detail and quality-oriented mindset.
Salary & Benefits
- Salary: As per company norms
Working with Novartis offers access to a globally structured benefits ecosystem, which may include:
- Competitive industry compensation
- Global exposure in regulatory affairs
- Learning and development programs
- Inclusive and diverse workplace culture
- Exposure to digital and AI-driven regulatory transformation
- Long-term career growth in global pharma operations
Selection Process
The hiring process may include:
- Online application screening
- Technical evaluation (Regulatory Affairs focused)
- Functional interviews with cross-functional teams
- Final HR discussion and offer release
Due to the urgent timeline, the process may be accelerated.
How to Apply
- Application Mode: Online Application
Candidates should apply through the official Novartis careers portal using the requisition ID mentioned above.
Important Dates
- Application Deadline: February 25, 2026
- Limited time remaining — candidates should apply immediately to avoid missing the opportunity.
Why Apply for This Pharma Job?
This role offers a strong entry point into global regulatory affairs within a top-tier pharmaceutical organization. Professionals will gain hands-on experience in CMC submissions, regulatory documentation systems, and digital regulatory workflows. The position provides exposure to global submission standards and modern tools including AI-enabled regulatory platforms. For candidates aiming to build a long-term career in regulatory affairs, this opportunity offers structured learning, global collaboration, and career advancement within one of the world’s most respected pharmaceutical companies.
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform that provides pharmaceutical and healthcare job updates for informational purposes only. We are not affiliated with Novartis or any hiring organization. Applicants should apply through the official company portal and verify all details independently.
Final Call-to-Action
If you have experience in regulatory CMC operations and are looking to work with a globally reputed pharmaceutical leader, this Novartis opportunity is not to be missed. With limited time left before the application deadline, submit your application immediately and take the next step in your regulatory affairs career.
