Senior Regulatory Coordinator

Overview

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).

What you'll do

• 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.

What you'll need

• Minimum of 3 years of experience in Regulatory Affairs or 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.
• Builds strong, effective relationships across teams and projects.
• Regulatory operational expertise.

Nice to have

• Skills desired: Clinical Study Reports, Data Analysis, Document Management, Life Science, Operational Excellence, Regulatory Compliance.

Details

• Location: Hyderabad (Office).