Senior Regulatory Coordinator

About the role

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).

What you'll do

• Ensure timely procurement of critical regulatory components (e.g., CPP, GMP certificates, registration samples, CoAs
• 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…
• 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

What you need

• 3–6 yrs of experience
• Regulatory affairs
• Negotiation
• Compliance
• C++
• GMP
• Any graduate