Regulatory Manager

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

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+)
• 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.