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
GCP Audit Hosting & Coordination
* Act as the primary coordinator for internal and external GCP audits
* Work in partnership with the Quality/Audit team to schedule, organise and host audits
* Coordinate SMEs and functional teams to support audit readiness
* Track and manage responses to audit queries
* Support the management of CAPAs and post-audit actions until close-out
Stakeholder & Cross-Functional Collaboration
* Serve as the central point of contact between Clinical Operations, Quality, Regulatory, CROs and Audit teams
* Track actions, risks and findings using structured tools
* Maintain high standards of confidentiality and regulatory integrity
Essential Key Requirements
* Proven experience working in GCP-regulated environments (clinical trials / clinical operations / clinical quality)
* Experience supporting GCP audits or inspection readiness
* Experience reviewing regulatory guidance and assessing its impact on SOPs or controlled documents
* Strong coordination skills with multiple SMEs and cross-functional teams
* Ability to track actions, CAPAs and regulatory changes
Highly Desirable
* Background in Regulatory Intelligence
* QA, Clinical Quality or GCP Compliance experience
* Experience working with CROs in regulated environments