Regulatory Intelligence Manager

5 days ago

Slough, United Kingdom Planet Pharma Full time

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 ResponsibilitiesOwn and coordinate Regulatory Intelligence (RIN) activities for GCSOMonitor and interpret global GCP regulations, guidance and industry standardsAssess regulatory impact and work with Subject Matter Experts (SMEs) to update and maintain controlled documents and SOPsAct as a central point of contact for CROs, confirming assessment of country and regulatory impacts to their SOPs and processesServe 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 closureRequired BackgroundWe'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 SystemsGCP Audit coordination or supportControlled document / SOP governanceCRO/vendor oversightInspection readinessInterested? Apply now for immediate consideration or contact Lloyd Broomes – LBroomes@planet-pharma.co.ukWe 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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