Senior Regulatory Coordinator

Novartis India; India; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Novartis India seeks a Senior Regulatory Coordinator to support development, lifecycle management, and registrations under close supervision. You will coordinate with RA GDD, CMC, and regional teams to ensure timely submissions and approvals.

This role involves obtaining regulatory documents, tracking milestones, and ensuring compliance with global and country requirements. You will drive knowledge sharing and coordinate with internal and external stakeholders to align project plans.

Qualifications

• Minimum of 3 years of experience in Regulatory Affairs or related pharmaceutical areas.
• Strong communication, interpersonal, negotiation and problem-solving skills.
• Delivery-focused, proactive mindset with flexibility to meet stretch targets.
• Ability to work in a global matrix environment across sites and functions.

Responsibilities

• Ensure timely procurement of regulatory components to support marketing authorization and lifecycle maintenance.
• Coordinate regulatory readiness with line functions, Country Organizations, and Regions to enable on-time submissions and approvals.
• Act as the single point of contact for Regulatory Affairs in NTO project teams and provide regulatory input on requirements, timelines, and risks for new submissions, LENC, and production transfers.
• Proactively identify regulatory risks, gaps, and trade-offs, and communicate issues, mitigations, and key achievements to project teams to avoid delays.
• 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.
• Contribute to non-project initiatives and continuous improvement activities within RA GDD.
• Drive knowledge sharing and capability building through lessons learned, trainings, and cross-functional engagements to support aligned regulatory strategies.
• Ensure clear alignment on roles and responsibilities across internal and external stakeholders.
• Maintain country requirement intelligence, including requirement lists, surveys, and direct engagement with Country Organizations.

Skills

Regulatory Affairs

Communication

Negotiation

Problem-solving

Delivery-focused

Global matrix work

Relationship building

Regulatory operations

Job description

Summary

The Senior Regulatory Coordinator (Sr. RC) works under close supervision to provide advanced 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 Senior Regulatory Coordinator (Sr. RC) works under close supervision to provide advanced 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 Sr. 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 Accountabilities

• Ensure 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 the single point of contact for Regulatory Affairs, representing RA in NTO project teams and global/regional forums and providing regulatory input on requirements, timelines, and risks for new submissions, LENC, and production transfers.
• Proactively identify regulatory risks, gaps, and trade‑offs, and communicate issues, mitigations, and key achievements to project teams to avoid delays.
• 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.
• Contribute to non‑project initiatives and continuous improvement activities within RA GDD.
• Drive knowledge sharing and capability building through lessons learned, trainings, and cross‑functional engagements to support aligned regulatory strategies.
• Ensure clear alignment on roles and responsibilities across internal and external stakeholders.
• Maintain country requirement intelligence, including requirement lists, surveys, and direct engagement with Country Organizations.

Essential Requirements

• Minimum of 3 years of experience in Regulatory Affairs,related areas of the pharmaceutical Industry
• Strong communication, interpersonal, negotiation,
• and problem-solving skills. Proactive, delivery-focused mindset with flexibility to meet stretch targets.
• Demonstrates agility and speed while maintaining focus on timely outcomes.Effectively plans, prioritizes, and coordinates workloads across teams.
• Works confidently in a global matrix environment across sites and functions.
• Build strong, effective relationships across teams and projects. Regulatory operational expertise.

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

Benefits and Rewards:

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