QA Regulatory Manager

Reporting to the Head of Quality UK, the Quality Assurance Regulatory Manager can be Located at a Choice of Company UK Locations, with the Opportunity for Some Remote Working

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.