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Permanent

Regulatory Affairs Manager - Pharmaceuticals

Hertfordshire
money-bag Negotiable
Posted 6 days ago

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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