Clinical Quality / Regulatory Intelligence professional
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
* Regulatory Intelligence (GCP / GxP)
* Clinical Quality Assurance / Quality Systems
* GCP Audit coordination or support
* Controlled document / SOP governance
* 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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