Regulatory & QA Lead — Aseptic GMP (UK)

RBW Consulting; Manchester; Hybrid; GBP 90,000 - 130,000; Full time

Job summary

RBW Consulting is seeking an experienced QA Regulatory Manager to oversee UK regulatory affairs and QA projects within a growing aseptic pharmaceutical business. You will drive GMP/GDP compliance, lead regulatory interactions with MHRA, and support IMP development across multiple UK sites.

You will partner with Quality Assurance, Regulatory Affairs, Operations and external regulators to shape quality systems, ensure inspection readiness, and support development and supply of IMPs in sterile

Qualifications

• Regulatory Affairs experience within sterile manufacturing or aseptic environments (5+ years).
• Hands-on experience supporting IMP development, clinical trial supply and IMPD preparation/review.
• Strong knowledge of UK/EU GMP, MHRA requirements and GxP compliance.
• Experience with regulatory inspections, audits and authority interactions.
• Ability to collaborate across manufacturing, QC, development and clinical teams.
• Degree in a scientific discipline; further QA/regulatory qualifications are advantageous.

Responsibilities

• Provide QA and regulatory leadership across UK facilities, ensuring GMP/GDP/MHRA compliance.
• Lead regulatory activities for IMP development, including IMPD reviews.
• Coordinate MHRA interactions, inspections, audits and responses.
• Maintain licences, variations and regulatory submissions.
• Harmonise quality systems across sites: deviations, CAPAs, change control, documentation, risk.
• Support QA projects for product development, technology transfer and validation in sterile environments.
• Review and approve QA documents: SOPs, validation protocols, batch records, reports.
• Serve as SME for aseptic GMP, IMP manufacture and regulatory expectations.

Skills

Regulatory leadership

GMP/GDP knowledge

MHRA liaison

Aseptic manufacturing

Quality systems

Documentation

CAPA

Change control

IMP development support

Regulatory inspections

Education

Science degree

QA/regulatory qualifications (adv)

Job description

RBW Consulting is seeking an experienced QA Regulatory Manager to oversee UK regulatory affairs and QA projects within a growing aseptic pharmaceutical business. You will drive GMP/GDP compliance, lead regulatory interactions with MHRA, and support IMP development across multiple UK sites.

You will partner with Quality Assurance, Regulatory Affairs, Operations and external regulators to shape quality systems, ensure inspection readiness, and support development and supply of IMPs in sterile