Regulatory Manager Job Central London area,City Of London England UK,Quality Assurance

Location: City Of London

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 with in 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 Power Point

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