QA Regulatory Manager
13 hours ago
Sheffield
QA Regulatory Manager Site‑based with flexibility for some remote working in the long‑term Locations: Flexible - can be based out of Sheffield, Preston, Stoke‑on‑Trent or Manchester 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. 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). What you’ll do: • Provide QA and regulatory leadership across all UK 6 facilities, ensuring consistent application of GMP, GDP and MHRA requirements., • Act as the regulatory lead for IMP development activities, including review and approval of IMPDs, clinical trial quality documentation and supply processes., • Lead interactions with MHRA and other regulatory bodies, supporting inspections, audits, responses and ongoing compliance commitments., • Ensure site licences, variations and regulatory submissions remain current and aligned with operational activities., • Harmonise and strengthen quality systems across multiple sites, covering deviations, CAPAs, change control, documentation and risk management., • Provide QA project support for product development, technology transfer and validation activities within sterile production environments., • Review and approve quality documentation, including SOPs, validation protocols, batch records and development reports., • Serve as subject matter expert for aseptic GMP, IMP manufacture and regulatory expectations. What you’ll bring: • Proven Regulatory Affairs experience within sterile manufacturing or aseptic environments (5 years+), • Proven QA management experience, • Hands‑on experience supporting IMP development, clinical trial supply and IMPD preparation/review., • Strong working knowledge of UK/EU GMP, MHRA regulatory requirements and GxP compliance., • Background in regulatory inspections, audits and authority interactions., • Ability to work effectively with manufacturing, QC, development and clinical teams., • Degree in a scientific discipline (or equivalent experience); further QA/regulatory qualifications are an advantage., • Excellent communication skills, able to influence and collaborate at all levels. Why Apply? 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. Key Words: 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