Scientific Officer, Centralised and Clinical Trial Licensing

5 days ago

Dublin, Ireland Health Products Regulatory Authority Full time

Location Hybrid

This is a Temporary , Full Time vacancy that will close in 15 days at 23:59 GMT .

The Vacancy

The role of the Scientific Officer is to support the evaluation and regulation of the safety and efficacy of medicinal products (drugs) in Ireland and the European Union and to provide technical support to the leadership teams in the Human Products Authorisation and Registration (HPAR) department.

Specifically, the Scientific Officer role will include ‘project management’ responsibilities for specific centralised case types and their associated activities, and the coordination, review and finalisation of documentation relating to new marketing authorisation applications, including line extension applications, within the HPAR Department, to facilitate the efficient licensing of medicinal products. Another major responsibility associated with this role involves process improvement activities to ensure operating models supporting centralised case management are effective and efficient. The Scientific Officer will also provide operational support to the Irish delegates of the Committee for Medicinal Products for Human Use (CHMP), Committee for Advanced Therapies (CAT) and Scientific Advice Working Party (SAWP).

The Scientific Officer will work closely and maintain effective working relationships with other members of the HPAR centralised portfolio team and with members of the wider HPAR department . This is critical to ensure effective and efficient co-ordination and co-operation across all areas of assessment and case management to support delivery of key strategic objectives of the HPAR Department, in accordance with the goals of the HPRA Strategic Plan, 2021 - 2025.

The Company

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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