Responsible for leading the regulatory strategy and ensuring compliance with UK and international regulations across the business. Acts as the primary liaison with regulatory bodies, oversees submissions, and advises senior leadership on emerging regulatory risks and opportunities. Ensures robust governance frameworks are in place to support business objectives. Responsibilities Provide independent regulatory oversight for all UK-based Uniphar Group businesses (including, but not limited to, Doncaster Pharma Ltd, Durbin Plc, Devonshire Pharma Ltd, and Dialachemist Ltd). Monitor and interpret applicable UK legislation governed by regulatory bodies such as the MHRA and Home Office, and ensure timely communication of updates to relevant businesses. Represent the group at trade association meetings (e.g. BAEPD, HDA), independently or with RPs as required. Develop, manage, and maintain regulatory SOPs in alignment with each entity’s Quality Management System (QMS). Oversee regulatory-related activities including risk assessments, deviations, CAPAs, and change controls, ensuring compliance with QMS and regulatory requirements. Collaborate cross-functionally across all UK entities to drive consistent regulatory compliance. Partner with RPs/QPs to make and document technical decisions on behalf of the UK Regulatory function. Maintain all UK regulatory licences (e.g. WDA(H), Home Office, MS Specials, PLPI), ensuring timely renewals and compliance. Provide expert guidance to internal stakeholders on regulatory requirements, ensuring clarity and alignment across the business. Lead responses to new or updated regulatory guidance, supporting RPs/QPs with impact assessments and compliance actions. Act as the primary point of contact with UK Regulatory Authorities, handling both inbound and outbound communications. Foster a culture of regulatory excellence, ethical conduct, and continuous compliance improvement. Deliverables Regulatory Operations & Licensing (UK & Ireland): Manage the UK Regulatory Team to ensure efficient workload distribution supporting both quality and commercial functions. UK PLPI Licences: Apply for new product applications upon request from the Commercial department. Maintain the existing portfolio, including submission of product variations and ongoing updates to the MHRA PI Call-in list. Cancel licences as directed by the Commercial department. Irish Parallel Import Licences: Apply for new product applications upon request from the Commercial department. Maintain the licence portfolio, including submission of variations, and perform periodic leaflet and label checks in compliance with HPRA regulations. Cancel licences as required. Product & Import Compliance: Ensure compliance with Trademark law in relation to repackaging of parallel-imported products. Provide regulatory assessments for label text for imported unlicensed medicines. Manage Notification of Imports to the MHRA for unlicensed medicines. Submit applications for import/export product licences as needed. Licensing Oversight & Risk Assessment: Assess regulatory and licensing requirements for existing and emerging markets; maintain a country regulation database to support RP decision-making. Manage applications and variations for WDA(H), Home Office, and MS Specials licences. Medical Devices (MedTech): Support UK regulatory compliance for medical devices, including adherence to UK MDR and MHRA requirements. Other Responsibilities: Perform additional regulatory duties as reasonably required by the Uniphar Group. Provide delegated cover during the absence of colleagues. Experience Minimum of 2 years’ experience in a regulatory role within the pharmaceutical or healthcare industry. Proven experience (at least 2 years) in a management or leadership position. Solid understanding of MHRA guidelines, particularly relating to Parallel Imports and unlicensed medicines. Familiarity with Good Distribution Practice (GDP) requirements and hands-on experience working with Quality Management Systems (QMS). Strong IT literacy, with the ability to navigate and understand complex systems, architectures, and digital connectivity. Excellent communication skills (both written and verbal), with the ability to engage effectively across departments and with external stakeholders to support regulatory compliance. Demonstrated ability to balance regulatory, quality, and commercial priorities to deliver compliant and business-aligned outcomes. Skilled in producing clear, concise documentation tailored to various audiences, with strong attention to detail and adaptability in writing style.