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.