ROLE
* Providing Regulatory Leadership with Accountability for Regulatory Compliance Across Seven UK Licensed Sites, Ensuring Consistent Application of GMP, GDP and MHRA Requirements
* Key Interface between Quality Assurance, Regulatory Affairs, Operations and External Regulatory Bodies, Ensuring Consistent Standards, Robust Systems and Inspection Readiness Across the Network
* Experience Commercial and Investigational Medicinal Product (IMP) Development, Including Early‑Phase and Clinical Trial Supply within a Sterile Manufacturing Environment.
* Combining Strategic Oversight with Hands‑On Regulatory Input, Supporting Routine Commercial Operations and Development Programmes
* Deputise for Head of Quality for UK Regulatory Issues
* Participate in Site Client Audits and Inspections by Regulatory Authorities
* QA Regulatory Lead for Commercial and IMP Activities
* Support Regulatory Interactions with MHRA and Other Authorities, Including Inspections, Audits, Responses and Ongoing Compliance Commitments
* Ensure Site Licences, Variations and Regulatory Submissions are Maintained and Aligned with Operational and Development Activities
* Review and Approve Quality and Regulatory Documentation, Including SOP’s, Batch Documentation, Validation Protocols and Development Reports
REQUIRED
* Degree or Higher in Quality, or Regulatory, or Equivalent Experience in a Pharmaceutical Setting
* Strong Background in Regulatory with a Minimum of 5 Years’ Experience
* Previous Managerial or Supervisory Experience with a Demonstrable Track Record of Strong Performance
* Experience of Pharmacovigilance, is Desirable
* Proven Regulatory Experience within Nuclear Medicine, Sterile Manufacturing or Aseptic Processing Environments
* Demonstrable Experience of Supporting Commercial and IMP Product Development, Including Clinical Trial Supply and IMPD Preparation/Review
* Strong Working Knowledge of UK and EU GMP, MHRA Regulatory Requirements and GxP Compliance
* Experience Working Across Multi‑Site Operations, with the Ability to Implement Consistent Quality Standards at Scale
* Background in Regulatory Inspections, Audits and Authority Interactions within a Licensed Manufacturing Environment
* Experience Collaborating Cross‑Functionally with Manufacturing, Quality Control, Development and Clinical Teams
* Confident Communicator, (Spoken and Written), with Ability to Operate at Operational and Senior Stakeholder Level
* Experienced in Microsoft Windows, Word, Excel and PowerPoint
Salary description
£80000.00 - £80000.00 per year