QA Regulatory Manager

RBW Consulting; Manchester; Hybrid; GBP 70,000 - 100,000; Full time

Job summary

RBW Consulting is seeking a QA Regulatory Manager to lead regulatory affairs for the UK business, ensuring GMP/GDP compliance and inspection readiness across multiple sites, with flexibility for remote work long-term. Reporting to Head of Quality, you will oversee GMP, regulatory submissions, and interactions with MHRA, while supporting IMP development and sterile manufacturing activities.

This pivotal role requires strong leadership, a scientific degree, and collaboration with operations, QC,

Qualifications

• Proven Regulatory Affairs experience in sterile manufacturing or aseptic environments.
• QA management experience.
• Hands-on experience supporting IMP development, clinical trial supply and IMPD preparation/review.
• Strong knowledge of UK/EU GMP, MHRA and GxP.
• Experience with regulatory inspections and authority interactions.
• Ability to collaborate with manufacturing, QC, development and clinical teams.
• Degree in a scientific discipline; QA/regulatory qualifications are a plus.

Responsibilities

• Provide QA and regulatory leadership across all UK facilities, ensuring GMP/GDP and MHRA compliance.
• Lead IMP development activities, including IMPD review and related QA documentation.
• Interface with MHRA and regulators, supporting inspections and responses.
• Ensure licences, variations and submissions stay current.
• Harmonise quality systems across sites, including deviations, CAPAs and change control.
• Support QA projects for product development, tech transfer and validation in sterile environments.
• Review and approve SOPs, validation protocols, batch records and reports.
• Serve as SME for aseptic GMP, IMP manufacture and regulatory expectations.

Skills

Regulatory Affairs

QA management

IMP development

Regulatory inspections

Cross-functional collaboration

Clear communication

Education

Degree in a scientific discipline

Job description

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