Job Description
We are supporting a global biopharmaceutical organisation to hire a GCP Regulatory Intelligence & Audit Coordinator to support its Global Clinical Study Operations (GCSO) function.
This role focuses on monitoring GCP-related regulatory guidance, coordinating updates to controlled clinical documents and SOPs, and acting as the point of contact for internal GCP audits. This is a coordination and compliance-focused role, not a delivery Project Manager position.
The successful candidate will work closely with Subject Matter Experts (SMEs), clinical teams, CROs, and Quality functions to ensure regulatory compliance and inspection readiness.
Key Responsibilities
Regulatory Intelligence & Document Governance
* Monitor and review new and updated GCP regulations, regulatory guidance and industry standards
* Assess regulatory impacts and coordinate with SMEs to update or create SOPs, controlled documents and procedural guidance
* Act as the RIN (Regulatory Intelligence Network) Coordinator for GCSO
* Assign regulatory topics to appropriate SMEs and track actions to completion
* Liaise with CROs to confirm assessment of global and local GCP regulatory requirements that may affect SOPs and clinical study conduct
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