Regulatory Affairs Associate
Brightwater
Tipperary
You’ve got at least two years’ experience in Regulatory Affairs and Compliance and are looking for your next step to grow your career. This role offers the opportunity to work for a start up pharma company. Responsibilities: Management of a specific portfolio of products. Co-ordination, preparation and submission of new MAAs (abridged) in the EU via national, MRP and DCP routes. Authoring and co-ordinating responses to questions from competent authorities. Co-ordination, preparation and submission of variations, renewals and transfers. Providing regulatory support for out-licensing activities in EU and non-EU territories including the provision of responses to queries arising from dossier audits. Planning and tracking of regulatory procedures through to completion in a timely manner. Liaising with other internal departments and external parties to generate supporting data for submissions. Reviewing documentation to ensure compliance with MA details and relevant guidelines and Directives. Skills & Competences: Practical experience of registration and variation procedures in the EU (national/MRP/DCP. Good understanding of the content and format of MA registration files (CTD. Knowledge and understanding of the requirements for product information (QRD template, user testing, Braille, etc.) Understanding of the application of change control to regulatory procedures. Knowledge and understanding of the EU regulatory framework. Accuracy and attention to detail. Strong verbal and written communication skills. Excellent organisational, prioritisation and time management skills. Good interpersonal skills. IT literacy in word processing, spread-sheets, document management. ‘Soft’ skills – team working, negotiation and influencing skills. The ideal candidate will have at least 2 years regulatory experience in the pharmaceutical industry, a life science or pharmacy background and a sound knowledge of European submission procedures and electronic applications (both NeeS and eCTD). The role is based in Clonmel, Co. Tipperary. For more on the role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.
2556 days ago