RA CMC Submission Coordinator

Novartis

2 - 5 years

Hyderabad

Posted: 11/06/2025

Job Description

Summary

Provide regulatory CMC operational, submission and compliance support to department in accordance to defined requirements to guarantee timely preparation of high-quality CMC regulatory submissions and associated compliance information throughout the life cycle.

About the Role

Major accountabilities:

  • Perform compliance and operational activities including QC check, DA checks and IND annual report writing. CMC contact for some countries and compliance/ regulatory database entry and reports
  • Create CMC submission documentation such as folders structure, metadata forms, RA request forms and act as data stewards in the applicable Regulatory Information 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 Operations
  • Perform super-user role of RA CMC documentation system/ support super-user for e.g. account requests/ modifications as assigned
  • Acquire and maintain GMP Certificates and Manufacturing Authorizations required for RA CMC submission in the Document Management System
  • Support other GSOC team members for end-to-end submission coordination

Key performance indicators:

  • High quality regulatory submissions and operational documentation
  • Timeliness of deliverables: No delays in approvals of clinical studies, global registration dossiers or variations due to late or inadequate CMC documentation and compliance support on matters within RA CMC control
  • Timely and accurate information / communication about operational and compliance issues within own department and to key stakeholders
  • Ensure that the operational activities and CMC regulatory documentation follow Novartis and eCTD guidelines. Regulatory compliance met in all compliance systems
  • Build and maintain collaborative partnerships with stakeholder
  • Partner with other GSOC team members to ensure business continuity

Minimum Requirements:
Work Experience:

  • If University entrance or completed vocational training: Preferably 2 years in regulatory and/or experience in the pharmaceutical industry
  • If Science Degree: Preferably 1 year in regulatory and/or experience in the pharmaceutical industry
  • Working experience in pharma industry data systems and data management
  • Ability to work successfully with global project teams and prioritize activities considering timelines and workload
  • Effective planning, organizational and interpersonal skills
  • Prior publishing experience desired
  • Computer literacy/IT systems literacy: Excellent data processing skills

Skills:

  • Being Resilient
  • Digital & Technology Savvy
  • Continuous Learning 
  • Interpersonal Savvy
  • Operational Excellence
  •  Project Excellence 

Education:

  • Minimum: General qualification for university entrance or completed vocational training
  • Desirable: Science Degree (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent

Languages:

  • Fluent English required (oral and written). Good written/spoken communication skills

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network(link is external)

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

About Company

Novartis is a leading global healthcare company headquartered in Basel, Switzerland. It specializes in the research, development, manufacturing, and marketing of innovative pharmaceuticals. Formed in 1996 through the merger of Ciba-Geigy and Sandoz, Novartis focuses on areas such as oncology, neuroscience, immunology, cardiovascular diseases, and gene therapies.With a strong commitment to scientific innovation, Novartis invests heavily in R&D and collaborates with biotech companies and academic institutions worldwide. The company operates in over 140 countries and serves millions of patients globally. Novartis is also known for its efforts in access to medicine, using programs like Novartis Access and Novartis Foundation to support underserved populations.

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