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Director quality regulatory affairs

London
UKPHARM LIMITED
Director
Posted: 16h ago
Offer description

Quality, Regulatory & Safety Director


United Kingdom | Full-Time (London 2 days per week) Strong package and 25% bonus



A growing UK pharmaceutical organisation is seeking to appoint an experienced Quality, Regulatory & Safety Director to lead its compliance and governance functions across the affiliate.

This senior leadership role is responsible for providing strategic direction and operational oversight across Regulatory Affairs, Pharmacovigilance, and Quality, ensuring full compliance with UK and EU regulatory requirements while supporting business growth and patient safety.


Key Responsibilities

* Provide strategic leadership across Quality, Regulatory Affairs, and Pharmacovigilance functions
* Ensure ongoing compliance with applicable GxP standards and maintain inspection readiness with the MHRA
* Oversee the UK Pharmacovigilance system, ensuring robust processes for adverse event reporting, reconciliation, and compliance
* Lead and maintain an effective Quality Management System (QMS), including GDP and supply chain quality oversight
* Direct regulatory strategy and lifecycle management activities, including submissions, variations, and labelling compliance
* Act as the UK lead for compliance risk management, audits, and regulatory inspections
* Lead, develop, and mentor direct reports across Quality, Regulatory, and Safety functions
* Collaborate cross-functionally to embed compliant and efficient ways of working across the organisation


Candidate Profile

* Degree in Pharmacy, Life Sciences, or a related discipline
* Significant leadership experience across at least two of the following areas: Quality, Regulatory Affairs, Pharmacovigilance
* Strong working knowledge of UK pharmaceutical regulatory requirements and GxP standards
* Demonstrated experience operating in an MHRA-regulated environment with inspection readiness responsibilities
* Proven ability to build and optimise systems within a growing or evolving organisation
* Strong leadership, communication, and stakeholder management skills



The Opportunity

This is a key leadership appointment offering the opportunity to shape and develop a scalable compliance framework within a growing UK affiliate. The successful candidate will play a critical role in ensuring regulatory excellence while enabling sustainable business growth and maintaining the highest standards of patient safety.

To apply or request further information, please submit your application via LinkedIn or contact us directly for a confidential discussion.

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