Regulatory Affairs Manager - Pharmaceuticals

• 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.

• 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.

• 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.

Smart4Sciences