Senior Regulatory Coordinator

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 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.

 

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.

 

Skills Desired

Clinical Study Reports, Data Analysis, Document Management, Life Science, Operational Excellence, Regulatory Compliance