Clonmel, Co. Tipperary – Permanent/Full or Part-Time
Niche Generics Limited is a generic pharmaceutical company whose products are registered and marketed in the UK, EU, South Africa, Australia and New Zealand. We currently have vacancies for experienced Regulatory Affairs Officer(s) based in our office in Clonmel, Co. Tipperary.
The ideal candidate will be a life science or pharmacy graduate, with a minimum of three years’ experience in regulatory affairs. Key responsibilities will include: review, compilation and submission of marketing authorisation applications in accordance with national and Mutual Recognition/Decentralised Procedures; post-approval regulatory activities; providing regulatory support to licensing partners for regulatory activities in EU and non-EU territories and active participation in regulatory project teams. Review of documentation to ensure compliance with MA details and relevant guidelines will also form part of the role. A broad knowledge of the key aspects of the European/UK regulatory system together with some level of commercial awareness is required. Strong communication and interpersonal skills are essential together with a methodical approach to regulatory affairs and a high degree of computer literacy including eCTD.
A competitive salary commensurate with experience is offered together with a generous benefits package.
To apply for this position please send your CV to firstname.lastname@example.org or fill the application form below.