Senior QA & Regulatory Lead - Aseptic IMPs

RBW Consulting; Woking; Hybrid; GBP 90,000 - 110,000; Full time

Job summary

RBW Consulting is seeking a QA Regulatory Manager to lead regulatory affairs for the UK business and drive QA projects within a growing aseptic pharmaceutical operation. This site‑based role offers flexibility for long‑term remote work and will interact with QA, Regulatory Affairs, Operations and regulators.

Reporting to the Head of Quality, you will shape quality systems, ensure inspection readiness, support IMP development and manage MHRA interactions across multiple sites.

Qualifications

• 5+ years regulatory affairs experience in sterile manufacturing or aseptic environments.
• Proven QA management experience.
• Hands-on experience with IMP development, clinical trial supply and IMPD review.
• Knowledge of UK/EU GMP, MHRA, and GxP compliance.
• Experience with regulatory inspections and authority interactions.

Responsibilities

• Provide QA and regulatory leadership across UK facilities, ensuring GMP, GDP and MHRA compliance.
• Lead IMP development activities, including review and approval of IMPDs and related QC documents.
• Manage interactions with MHRA and other authorities, supporting inspections and responses.
• Ensure site licences, variations and regulatory submissions remain current.
• Harmonise and strengthen quality systems across multiple sites, including deviations, CAPAs and change control.
• Support product development, technology transfer and validation in sterile environments.
• Review and approve SOPs, validation protocols and batch records.

Skills

Regulatory Affairs

QA management

Communication skills

Education

Degree in scientific discipline

Job description

RBW Consulting is seeking a QA Regulatory Manager to lead regulatory affairs for the UK business and drive QA projects within a growing aseptic pharmaceutical operation. This site‑based role offers flexibility for long‑term remote work and will interact with QA, Regulatory Affairs, Operations and regulators.

Reporting to the Head of Quality, you will shape quality systems, ensure inspection readiness, support IMP development and manage MHRA interactions across multiple sites.