Senior Regulatory Affairs Officer - Tipperary

Role Description

Our client, a pharmaceutical company now have an immediate requirement for a Senior Regulatory Affairs Officer.

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).

Role & 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

They offer a competitive salary and attractive benefits.

For more information and to apply for this role please call Linda on +353 1 2784671 or e-mail ldunne@thornshaw.com

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Www.thornshaw.com Tel: +353 1 2784671

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