Location: Sheffield / Manchester / Blackburn / Stoke-on-Trent (can be based at either of these locations)
Permanent | On-site (5 days/week)
We’re supporting a growing pharmaceutical manufacturing organisation operating across several UK sites. With expanding development programmes, evolving regulatory expectations and increased operational complexity, this is an exciting opportunity to step into a pivotal role that blends Regulatory Affairs and Quality Assurance.
As Regulatory QA Manager, you’ll provide regulatory leadership across multiple licensed facilities, ensuring inspection readiness, GMP/GDP compliance and robust quality systems. This is a hands‑on, influential role where you will act as the main liaison with regulatory authorities, support both commercial and IMP activities, and drive harmonisation of standards across the network.
This position is ideal for a strong Regulatory professional with QA exposure who is ready to shape regulatory frameworks, strengthen quality culture and support cutting‑edge sterile product operations.
Key Responsibilities:
- Provide regulatory and QA oversight across multiple licensed sterile manufacturing sites, ensuring consistent GMP, GDP and MHRA compliance.
- Act as the primary contact for regulatory authorities, supporting inspections, audits, submissions and ongoing compliance commitments.
- Lead regulatory activities for commercial and IMP products, including review of IMPDs, pre‑submission work, post‑approval activities and clinical trial supply documentation.
- Maintain and manage site licences, variations and regulatory submissions.
- Support and advise site teams on quality and regulatory improvements, inspection readiness and continual improvement initiatives.
- Oversee harmonisation of quality systems including deviations, CAPAs, change control, documentation and risk management.
- Provide QA input into product development, validation, technology transfer and sterile processes.
- Contribute to implementation of a new electronic Document/Quality Management System.
- Collaborate with QA, QC, Operations and QP teams across the UK network.
Requirements:
- Degree or higher in a scientific, quality or regulatory discipline (or equivalent experience).
- Minimum 5 years’ Regulatory Affairs experience, including IMP and clinical trial supply exposure.
- Strong knowledge of UK/EU GMP, MHRA expectations and GxP compliance.
- Experience in radiopharmacy, sterile manufacturing, aseptic processing or related environments (highly desirable).
- Some Quality Assurance experience, capable of supporting QA initiatives and projects.
- Experience working across multi‑site operations and regulatory inspections.
- Excellent communication, organisation and stakeholder‑management skills.
- Self‑motivated, detail‑oriented and able to work proactively and independently.
- Proficiency in Microsoft Office applications.
We're moving quickly on this role - if you're interested, apply early as the advert may close ahead of schedule.
