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Regulatory Policy and Operations Lead, Operations Management & Regulatory Policy - Compliance

Salary €83,619-€105,541 per annum (incremental scale)
Location Hybrid
{Mergefield Value}
{Mergefield Value}

This is a Temporary, Full Time vacancy that will close in {x} days at {xx:xx} BST.

Reporting to the Director of Compliance, this position will be primarily responsible for ensuring cross functional regulatory excellence, operational efficiency, and effective stakeholder engagement across the Compliance Department. This role combines core management responsibilities with high-level executive support, directly assisting the Director of Compliance and the Compliance Planning Manager in driving departmental objectives, process improvements, and stakeholder communications. This role acts as a key liaison across the department and organisation, supporting both strategic and operational priorities and coordinating key information to both stakeholders. This includes oversight of processes relating to regulatory and Compliance Management action across inspection functions, supports policy development, and champions continuous improvement and knowledge management within the department. This role will act as a decision-making role model, empowering others to take ownership, constructively challenging assumptions, and facilitating diverse viewpoints to achieve collaborative, strategic decisions.

The Compliance function at the HPRA covers several regulatory frameworks including Medicines (Human and Vet), Cosmetics, Blood, Tissues and Organs, Controlled Drugs, together with various associated licencing, registration, inspection and surveillance programmes. It also supports the organisation on Borderline Classification, Medicines Shortage coordination and Enforcement.

The role will lead the Regulatory Operations section working closely with the Director of Compliance and the Planning Manager as part of the Compliance function. The position will also work closely and maintain effective working relationships and support the extended compliance management team, colleagues within the various sections of the compliance department and other departments of the HPRA. The role will be responsible for leading change and driving development initiatives, contributing meaningfully to the enhancement of systems, processes, resources, and team capabilities to support the successful delivery of Regulatory Operations objectives.

We are the Health Products Regulatory Authority (HPRA) and we regulate medicines and devices for the benefit of people and animals. We are committed to excellence in health product regulation through science, collaboration and innovation.

Our remit and regulatory functions include human and veterinary medicines, clinical trials, medical devices, controlled drugs, blood and blood components, tissues and cells, and cosmetic products.

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