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Regulatory Intelligence and Audit Coordination Specialist

2 weeks ago

Slough, Slough, United Kingdom BioTalent Full time £40,000 - £80,000 per year

Regulatory Intelligence & Audit Coordination Specialist

12-Month Contract | Global Pharmaceutical Company

I'm supporting a leading global biopharma organisation seeking an experienced Regulatory Intelligence specialist to join their Global Clinical Safety Operations (GCSO) function. This role focuses on managing Regulatory Intelligence Needs (RIN) requirements, coordinating with internal SMEs, and supporting internal quality audits.

Key Responsibilities:


• Serve as the RIN Coordinator for GCSO, managing all regulatory intelligence requirements.


• Review new and updated regulations, identify impacted areas, and assign the appropriate SMEs for assessment.


• Work with SMEs to ensure controlled documents are updated in line with regulatory and guidance changes.


• Act as the main point of contact for verifying CRO assessments of country-specific regulations impacting SOPs and studies.


• Host internal quality audits in partnership with the internal auditing team.


• Coordinate and support SMEs during audits, ensuring timely and accurate responses.


• Assist with post-audit activities, including tracking findings, responses, and CAPA closure.

Requirements:


• Strong background in Regulatory Intelligence within pharma/biotech.


• Experience coordinating SME reviews of regulatory changes.


• Understanding of GxP, Quality Systems, and audit processes.


• Excellent organisational and communication skills.


• Ability to manage multiple stakeholders and act as a central point of coordination.