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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

We are supporting a global pharmaceutical organisation in hiring an experienced Clinical Quality / Regulatory Intelligence professional to support their Global Clinical Sciences & Operations (GCSO) quality function. This is a highly visible role supporting GCP quality systems, regulatory intelligence, audit hosting and CRO oversight within a global clinical environment. Key Responsibilities • Own and coordinate Regulatory Intelligence (RIN) activities for GCSO, • Monitor and interpret global GCP regulations, guidance and industry standards, • Assess regulatory impact and work with Subject Matter Experts (SMEs) to update and maintain controlled documents and SOPs, • Act as a central point of contact for CROs, confirming assessment of country and regulatory impacts to their SOPs and processes, • Serve as an Audit Host / Coordinator for internal GCP quality audits (you will not conduct audits – you will coordinate activities and SMEs), • Support audit readiness, responses, CAPAs and follow-up activities through to closure Required Background We’re particularly keen to speak with professionals who have experience in one or more of the following: • Regulatory Intelligence (GCP / GxP), • Clinical Quality Assurance / Quality Systems, • GCP Audit coordination or support, • Controlled document / SOP governance, • CRO/vendor oversight, • Inspection readiness Interested? Apply now for immediate consideration or contact Lloyd Broomes – We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age. Planet Pharma is an Employment Business providing Global Staffing services.

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