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Job Details

Regulatory Affairs Officer

Company: Thornshaw Recruitment
Location: Tipperary, Republic of Ireland
Reference: LCD9137
Closing Date: 18 Nov 16
Type: Full Time
Salary (£): Negotiable

Job Summary:

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


Our client, a pharmaceutical company now have a requirement for a 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 authoritie
  • 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 skill
  • 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

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

Apply for this job: Regulatory Affairs Officer

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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