Regulatory Intelligence Manager

2 days ago


Slough Berkshire, 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 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 – LBroomes@planet-pharma.co.uk 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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