QA Regulatory Lead – Sterile GMP & IMPs

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

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,