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Join a pharmaceutical leader dedicated to improving access to essential medicines and make your mark in regulatory excellence.
We are seeking a proactive and experienced Regulatory Affairs Manager to lead their Regulatory Affairs team and ensure full compliance with EU and GDP regulations. If you are a collaborative leader with a strong background in pharmaceutical distribution and regulatory affairs, this could be your next career-defining move.

Key Responsibilities

Lead, motivate, and supervise the regulatory approval team.Act as the main point of contact for team members and facilitate effective collaboration.Maintain and oversee accurate quality records, CAPAs, deviations, and SOPs.Coordinate with manufacturers and oversee recall operations when necessary.Conduct supplier and customer audits; lead self-inspections and follow-up actions.Ensure the appropriate handling and final disposition of returned, rejected, or falsified products.Oversee the relabelling and repackaging processes to comply with EU GDP standards.Ensure GDP training programs are implemented and continuously maintained.Maintain all documentation and licenses required for pharmaceutical distribution and regulatory compliance.Approve quality-related decisions, return-to-stock processes, and participate in distribution oversight.

What We're Looking For

Degree in Pharmacy or a related scientific discipline.Significant experience in Regulatory Affairs, ideally within pharmaceutical distribution/wholesale.In-depth knowledge of UK and EU pharmaceutical regulations (including GDP).Strong organisational and problem-solving skills, with attention to detail.Excellent communication and stakeholder management abilities.

What's on Offer

Competitive salary and performance-based incentives.Health insurance and comprehensive benefits package.Genuine opportunities for career development and growth.Flexible, collaborative, and inclusive work culture within a global company.

Ready to elevate your regulatory career?
Apply now and take your next step in a forward-thinking pharmaceutical environment or contact Gareth Gooley at Smart4Sciences on for more information.

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Regulatory Affairs Manager

I am working with a pharmaceutical/ Medical Device manufacturing site based in Deeside specialising in challenge meals, this is a good opportunity for a experienced Regulatory Affairs Manager to develop their career with an expanding company.

Key responsibilities for the Regulatory Affairs Manager

Develop and implement regulatory strategies for FDA and MHRA submissions.Lead the preparation, submission, and lifecycle management of regulatory dossiers.Work closely with the director with FDA and MHRA, coordinating meetings, and inspection readiness.Monitor changes in global regulatory landscapes and assess impact on ongoing and future projects.Provide regulatory guidance during product development, labelling, and promotional review processes.

Requirements for the Regulatory Affairs Manager

Bachelor's degree in a scientific discipline or a related subject.Minimum 5 years' experience in regulatory affairs, with demonstrable expertise in both FDA and MHRA regulatory processes.Strong knowledge of global regulatory standardsProven success in authoring and managing regulatory submissions and renewals.Excellent communication, leadership, and project management skills.

Benefits for the Regulatory Affairs Manager

25 holidays per year + Bank HolidaysChristmas shutdown.Cycle to work schemePrivate healthcareHigh street discount scheme

To apply for the Regulatory Affairs Manager or here more information, please contact Liam Shannon at Smart4Sciences on 01925 239723 or email me at

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