Senior QA/RA Manager — Path to Qualified Person (QP)

RBW Consulting; Manchester; On-site; GBP 85,000 - 110,000; Full time

Benefits offered by this job

Leadership opportunities

Internal Qualified Person (QP) pathway

Career progression & development

Job summary

RBW Consulting is seeking a QA/RA Manager in the UK to lead regulatory affairs across licensed pharmaceutical products from a GMP site. The role offers base locations including Manchester and other sites, with responsibility for submissions and regulatory liaison.

The position provides a clear path toward an internal Qualified Person (QP) position and involves cross-functional collaboration with Quality, Manufacturing, and Supply Chain to ensure compliance and continuity.

Qualifications

• Significant Regulatory Affairs experience within the pharmaceutical industry.
• Strong knowledge of UK regulatory requirements and lifecycle management.
• Experience leading regulatory submissions and health authority interactions.
• Good understanding of GMP and Quality Management Systems.
• Ability to coordinate across functions and manage priorities.
• Excellent communication and stakeholder management.

Responsibilities

• Lead and coordinate Regulatory Affairs activities across licensed pharmaceutical products.
• Prepare, review and maintain regulatory submissions including variations, renewals, and new marketing authorisation applications.
• Act as the primary liaison with regulatory authorities including MHRA.
• Provide regulatory strategy and guidance to cross-functional teams throughout the product lifecycle.
• Review technical and regulatory documentation to ensure compliance with applicable GMP and regulatory requirements.
• Support change controls, deviations, CAPAs and quality investigations from a regulatory perspective.
• Collaborate with Quality, Manufacturing, Supply Chain and Technical Services teams to ensure continued compliance and supply continuity.
• Contribute to regulatory intelligence activities and assess the impact of evolving regulations on the business.

Skills

Regulatory affairs

UK regulatory knowledge

Stakeholder management

Regulatory submissions

GMP/QA understanding

Communication skills

Job description

RBW Consulting is seeking a QA/RA Manager in the UK to lead regulatory affairs across licensed pharmaceutical products from a GMP site. The role offers base locations including Manchester and other sites, with responsibility for submissions and regulatory liaison.

The position provides a clear path toward an internal Qualified Person (QP) position and involves cross-functional collaboration with Quality, Manufacturing, and Supply Chain to ensure compliance and continuity.