Senior Regulatory Compliance Manager

Walker Cole International is supporting a leading pharmaceutical organisation in the search for a Senior Regulatory Compliance Manager. This is a national, hybrid opportunity responsible for providing regulatory and quality leadership across a multi-site GMP manufacturing network, ensuring ongoing compliance with UK and EU regulatory requirements while supporting both commercial and development activities.

Responsibilities of the Senior Regulatory Compliance Manager

• Lead regulatory compliance activities across multiple GMP manufacturing sites, ensuring inspection readiness and adherence to MHRA, GMP and GDP requirements.
• Act as the key quality and regulatory interface between Quality Assurance, Operations, Regulatory Affairs and external regulatory authorities.
• Support regulatory inspections, audits, licence maintenance, variations and regulatory submissions across the business.
• Drive continuous improvement initiatives across quality systems including deviations, CAPAs, change controls and risk management processes.

Requirements for the Senior Regulatory Compliance Manager

• Degree qualified in a Life Science, Pharmacy, Quality, Regulatory Affairs or related discipline.
• Proven regulatory compliance experience within a GMP-regulated pharmaceutical, biotechnology, sterile manufacturing or aseptic processing environment.
• Strong knowledge of UK and EU GMP regulations, MHRA requirements and wider GxP compliance.
• Experience supporting regulatory inspections, audits and interactions with competent authorities.

Regulatory Affairs | Regulatory Compliance | Quality Assurance | GMP | GDP | GxP | MHRA | Quality Systems | QMS | CAPA | Change Control | Deviations | Risk Management | Inspection Readiness | Regulatory Audits | Regulatory Inspections | Sterile Manufacturing | Aseptic Processing | Clinical Trials | IMP | IMPD | Pharmacovigilance