About the job

QA/ RA Manager

Location: Can be based out of SW London, Guildford, Stoke-on-Trent, Dinnington, Preston or Manchester.

We are seeking a QA/ RA Manager to join a growing pharmaceutical manufacturing organisation, taking ownership of regulatory activities while supporting quality operations across the site. This is an excellent opportunity for an experienced Regulatory Affairs professional looking to broaden their influence within a GMP environment, with the longer-term opportunity to apply for an internal Qualified Person (QP) position.

Key ResponsibilitiesLead 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.

Required Candidate Profile:Significant Regulatory Affairs experience within the pharmaceutical industry.
Strong knowledge of UK pharmaceutical regulations and lifecycle management activities.
Experience supporting or leading regulatory submissions and health authority interactions.
Good understanding of GMP requirements and Quality Management Systems.
Ability to work effectively across multiple functions and manage competing priorities.
Excellent communication and stakeholder management skills.

Other Desirable Experience:Previous exposure to sterile products or highly regulated manufacturing environments.
Experience working with IMPs.
Progressing through QP training or approaching QP eligibility.
Candidates nearing completion of a QP programme are particularly encouraged to apply.

What's on Offer?A highly visible QA/RA leadership opportunity with a strong emphasis on Regulatory Affairs.
The opportunity to develop towards an internal Qualified Person position, subject to eligibility and business requirements.
A collaborative environment that supports professional development and career progression.

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Responsibilities

About the job

QA/ RA Manager

Location: Can be based out of SW London, Guildford, Stoke-on-Trent, Dinnington, Preston or Manchester.

Key ResponsibilitiesLead 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.

Required Candidate Profile:Significant Regulatory Affairs experience within the pharmaceutical industry.
Strong knowledge of UK pharmaceutical regulations and lifecycle management activities.
Experience supporting or leading regulatory submissions and health authority interactions.
Good understanding of GMP requirements and Quality Management Systems.
Ability to work effectively across multiple functions and manage competing priorities.
Excellent communication and stakeholder management skills.

Other Desirable Experience:Previous exposure to sterile products or highly regulated manufacturing environments.
Experience working with IMPs.
Progressing through QP training or approaching QP eligibility.
Candidates nearing completion of a QP programme are particularly encouraged to apply.

What's on Offer?A highly visible QA/RA leadership opportunity with a strong emphasis on Regulatory Affairs.
The opportunity to develop towards an internal Qualified Person position, subject to eligibility and business requirements.
A collaborative environment that supports professional development and career progression.