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Regulatory Affairs Manager

Smart4 Sciences
Stevenage
3 days ago
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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 experiencedRegulatory Affairs Managerto 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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