Regulatory Manager

<p><strong>QA Regulatory Manager</strong></p><p><br><br>Remember to check your CV before applying Also, ensure you read through all the requirements related to this role.<br></p><p>Site‑based with flexibility for some remote working in the long‑term</p><p>Locations: Flexible - can be based out of Sheffield, Preston, Stoke‑on‑Trent or Manchester</p><p><br></p><p>Are you an experienced QA and Regulatory professional ready to take on a pivotal leadership role within an exciting growing business? Our client is looking for a QA Regulatory Manager to oversee regulatory affairs for the UK business and assist with QA projects.</p><p>Reporting directly to the Head of Quality, this is a key strategic position interfacing with Quality Assurance, Regulatory Affairs, Operations and external regulators. You’ll play a critical role in shaping quality systems, ensuring inspection readiness, and supporting the development and supply of Investigational Medicinal Products (IMPs).</p><p><br></p><p><strong>What you’ll do:</strong></p><ul><li>Provide QA and regulatory leadership across all UK 6 facilities, ensuring consistent application of GMP, GDP and MHRA requirements.</li><li>Act as the regulatory lead for IMP development activities, including review and approval of IMPDs, clinical trial quality documentation and supply processes.</li><li>Lead interactions with MHRA and other regulatory bodies, supporting inspections, audits, responses and ongoing compliance commitments.</li><li>Ensure site licences, variations and regulatory submissions remain current and aligned with operational activities.</li><li>Harmonise and strengthen quality systems across multiple sites, covering deviations, CAPAs, change control, documentation and risk management.</li><li>Provide QA project support for product development, technology transfer and validation activities within sterile production environments.</li><li>Review and approve quality documentation, including SOPs, validation protocols, batch records and development reports.</li><li>Serve as subject matter expert for aseptic GMP, IMP manufacture and regulatory expectations.</li></ul><p><br></p><p><br></p><p><strong>What you’ll bring:</strong></p><ul><li>Proven Regulatory Affairs experience within sterile manufacturing or aseptic environments (5 years+)</li><li>Proven QA management experience</li><li>Hands‑on experience supporting IMP development, clinical trial supply and IMPD preparation/review.</li><li>Strong working knowledge of UK/EU GMP, MHRA regulatory requirements and GxP compliance.</li><li>Background in regulatory inspections, audits and authority interactions.</li><li>Ability to work effectively with manufacturing, QC, development and clinical teams.</li><li>Degree in a scientific discipline (or equivalent experience); further QA/regulatory qualifications are an advantage.</li><li>Excellent communication skills, able to influence and collaborate at all levels.</li></ul><p><br></p><p><strong>Why Apply?</strong></p><p>This is a rare opportunity to take on a high‑impact role within a specialised and mission‑driven aseptic pharmaceutical operation. You’ll shape the regulatory framework supporting both commercial products and innovative clinical development programmes—while working with a collaborative, highly skilled team committed to improving patient outcomes. xwzovoh </p><p><br></p><p><strong>Key Words:</strong></p><p>Regulatory Affairs, RA, QA, quality assurance, manager, senior, supervision, supervisor, leader, lead, IMP, clinical, commercial, GMP, sterile, aseptic, injectables, injection, terminal sterilization, radiopharmaceutical, radiopharma, nuclear medicine.</p>