Job Description

CK Group are recruiting on behalf of a global pharmaceutical company specialising in the discovery, development, and commercialisation of medicines for severe diseases within neurology and immunology.
This is a 12-month contract opportunity for a Process Quality Excellence Specialist, supporting the Global Clinical Safety Operations (GCSO) function.
The Role:
This is a hands-on, coordination-focused quality role, suited to someone comfortable working across audits, regulatory intelligence, and cross-functional stakeholders. The successful candidate will act as a key point of contact for both regulatory intelligence notifications (RIN) and internal quality audits.
Key Responsibilities:
Regulatory Intelligence & RIN Coordination

• Act as the RIN Coordinator for GCSO, managing Regulatory Intelligence Notifications and associated actions
• Review new and updated regulations and guidance, assessing impact on controlled documents
• Identify and assign appropriate Subject Matter Experts (SMEs) based on regulatory topics
• Track actions and timelines, ensuring follow-up and completion
• Act as a point of contact to confirm CRO assessment of regulatory and country-specific requirements impacting SOPs and clinical studies

Audit Coordination:

• Act as Audit Host for internal quality audits
• Coordinate with the internal Auditing team and relevant SMEs and functions
• Prepare for audits, manage documentation requests, and track timelines
• Support SMEs during audits by coordinating responses to auditor queries
• Manage post-audit activities including findings, CAPAs, and follow-up actions through to audit closure

Your Background:

• Experience in Regulatory Intelligence, RIN coordination, or regulatory compliance within a GxP environment
• Prior involvement in quality audits, either as an audit host or audit support function
• Strong understanding of GCP and clinical research regulatory requirements
• Excellent organisational, coordination, and communication skills
• Ability to work across multiple stakeholders and manage timelines effectively
• QA background welcomed but not essential

Apply:
Please send your CV and cover letter in English. It is essential that applicants hold entitlement to work in the UK. Please quote job reference 173257in all correspondence.
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