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Regulatory Coordinator

Novartis AG

  • East Hanover, NJ
  • 2 days ago

    Highlights

    The Regulatory Coordinator (RC) works under close supervision to provide operational and compliance support for assigned development, line extension, and lifecycle management projects, including registrations, approvals, post‑approval commitments, and production transfer initiatives driven by Novartis Technical Operations (NTO).The RC collaborates closely with RA GDD Development and CMC teams, regional stakeholders (MoW, LACan, EU, China, Japan), NTO, and Quality Assurance to align planning, execution, communication, and successful completion of assigned projects. Demonstrate contribution to strengthen country intelligence, stakeholder alignment, and knowledge sharing within RA.Minimum RequirementMinimum of 2 years of experience in Regulatory Affairs, related areas of the pharmaceutical IndustryStrong communication, interpersonal, negotiation, and problem‑solving skillsProactive, delivery‑focused, with flexibility to meet stretch targetsDemonstrates speed and agility while delivering timely outcomesEffectively plans, prioritizes, and manages workloadWorks confidently in a global matrix environmentBuilds strong, effective cross‑functional relationship.

    Numbers & Facts

    LocationEast Hanover, NJ
    IndustryBiotechnology/Pharmaceuticals
    Company Size10,000 employees or more
    Year Founded1996

    Description

    Job ID

    REQ-10084807

    Jul 30, 2026

    India

    Available in: English

    Summary

    The Regulatory Coordinator (RC) works under close supervision to provide operational and compliance support for assigned development, line extension, and lifecycle management projects, including registrations, approvals, post‑approval commitments, and production transfer initiatives driven by Novartis Technical Operations (NTO).The RC collaborates closely with RA GDD Development and CMC teams, regional stakeholders (MoW, LACan, EU, China, Japan), NTO, and Quality Assurance to align planning, execution, communication, and successful completion of assigned projects.

    About the Role

    Major AccountabilitiesEnsure timely procurement of critical regulatory components (e.g., CPP, GMP certificates, registration samples, CoAs, and other regulatory documents) to support marketing authorization and lifecycle maintenance, in collaboration with internal functions (NTO, Reg CMC, RA Ops, Global Labelling, SCM, Tech Ops) and external stakeholders (Health Authorities, Consular Services, service providers).Coordinate regulatory readiness with line functions, Country Organizations, and Regions to enable on‑time submissions and approvals.Act as single point of contact for Regulatory Affairs in projects and governance forums (eg. NTO project teams and global/regional forums)Provide regulatory input on requirements, timelines, and risks for submissions and transfers.Proactively identify, manage, and communicate regulatory risks and mitigations.Track and manage project progress, including timelines, dossier deliverables, and regulatory milestones.Ensure quality and compliance with global and country‑specific regulatory requirements, and adherence to internal policies and processes.Demonstrate contribution to strengthen country intelligence, stakeholder alignment, and knowledge sharing within RA.Minimum RequirementMinimum of 2 years of experience in Regulatory Affairs, related areas of the pharmaceutical IndustryStrong communication, interpersonal, negotiation, and problem‑solving skillsProactive, delivery‑focused, with flexibility to meet stretch targetsDemonstrates speed and agility while delivering timely outcomesEffectively plans, prioritizes, and manages workloadWorks confidently in a global matrix environmentBuilds strong, effective cross‑functional relationship

    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-cultureBenefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally.Read our handbook (PDF 30 MB)

    Division

    Development

    Business Unit

    Development

    Location

    India

    Site

    Hyderabad (Office)

    Company / Legal Entity

    IN10 (FCRS = IN010) Novartis Healthcare Private Limited

    Functional Area

    Research & Development

    Job Type

    Full time

    Employment Type

    Regular

    Shift Work

    No

    Accessibility and accommodationNovartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

    Research & Development Development India

    Job ID

    REQ-10084807

    Regulatory Coordinator

    Apply to Job

    Job ID

    REQ-10084807

    Regulatory Coordinator

    Apply to Job

    About Company

    Novartis provides healthcare solutions that improve and extend people’s lives. We use science-based innovation to address some of society’s most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible. Our company is focused on industry-leading divisions with innovation power and global scale: pharmaceuticals, eye care and generic medicines Novartis is headquartered in Basel, Switzerland. Novartis Group companies employ approximately 120,000 associates and its products are available in more than 180 countries around the world.

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