Regulatory Coordinator
Regulatory Coordinator
Refined job description
ROLE
– Ensure timely procurement of critical 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 single point of contact for Regulatory Affairs in projects and governance 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
REQUIREMENTS
– Minimum of 2 years of experience in Regulatory Affairs, related areas of the pharmaceutical Industry
– Strong communication, interpersonal, negotiation, and problem‑solving skills
– Proactive, delivery‑focused, with flexibility to meet stretch targets
– Demonstrates speed and agility while delivering timely outcomes
– Effectively plans, prioritizes, and manages workload
– Works confidently in a global matrix environment
– Builds strong, effective cross‑functional relationship
– Clinical Trials, Collaboration, Detail-Oriented, Project Planning, Regulatory Compliance skills
Full job description
Job Description 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.
Job Description
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 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 Requirement
Minimum of 2 years of experience in Regulatory Affairs related areas of the pharmaceutical Industry
Strong communication interpersonal negotiation and problem‑solving skills
Proactive delivery‑focused with flexibility to meet stretch targets
Demonstrates speed and agility while delivering timely outcomes
Effectively plans prioritizes and manages workload
Works confidently in a global matrix environment
Builds strong effective cross‑functional relationship
Skills Desired
Clinical Trials Collaboration Detail-Oriented Project Planning Regulatory Compliance