About this role
We are delighted to be working with a leading pharmaceutical company in Dublin. This exciting new opportunity will see you manage a portfolio of products across multiple countries.
The company is experiencing significant growth in Ireland, the UK and internationally, with market-leading brands across OTC and Prescription medicines. This is a permanent role with excellent salary prospects and offers flexible working arrangements, including hybrid or remote options.
Candidates may be based in Ireland, the UK or Europe, but all must have existing right to work in Ireland, the UK or EU citizenship.
Key responsibilities:
* Develop and implement regulatory strategies to support product development and lifecycle management.
* Lead a team of Regulatory Affairs Officers to ensure compliance with all relevant regulations and standards.
* Integrate new portfolio acquisitions into multiple markets efficiently.
* Lead projects to identify gaps in dossiers and devise plans to resolve these gaps.
* Collaborate with Regulatory Authorities and lead meetings to discuss regulatory aspects.
* Monitor and interpret regulatory trends and changes, keeping the company appraised of developments.
* Work cross-functionally with Quality and Commercial/Marketing teams to achieve company objectives.
Knowledge & Experience:
* Highly resilient and adaptable, able to work under pressure and within time constraints.
* Strong knowledge of global regulatory frameworks, including MRP, DCP and CP.
* Knowledge of medical devices highly desirable.
* Excellent attention to detail and organisational skills.
* Able to work on own initiative and take responsibility for course of action.
* 8-10 years previous experience essential.