QA Regulatory Manager

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

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