Regulatory Manager
26 days ago
London
Reporting to the Head of Quality UK, the 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