Regulatory Affairs Officer

Tipperary  ‐ Onsite
This project has been archived and is not accepting more applications.
Browse open projects on our job board.

Keywords

Description

My client is a company dedicated to the successful registration and launch of generic pharmaceutical products throughout the EU, South Africa, Australia, New Zealand and MENA territories. Due to their continued expansion they are currently looking to grow their regulatory team which is based in Tipperary. The ideal candidate will have a sound knowledge of European submission procedures and electronic applications (both NeeS and eCTD).

Responsibilities/Tasks of the regulatory affairs role:
*Management of a specific portfolio of products
*Submission of new MAAs (abridged) in the EU via national, MRP, DCP routes
*Post-licensing activities (variations, renewals, PSURs, etc.)
*Providing regulatory support for out-licensing activities in EU and non-EU territories
*Planning and tracking of regulatory procedures through to completion in a timely manner
*Liaising with other departments and external parties to generate supporting data for submissions
*Reviewing documentation to ensure compliance with MA details and relevant guidelines and Directives

Key Competences for the regulatory affairs roles:
*Knowledge and application of registration procedures in Europe (national/MRP/DCP)
*Knowledge and application of the content and format of registration files (CTD)
*Knowledge and application of requirements for product information (QRD template, user testing, Braille, etc.)
*Understanding of pharmacovigilance and the role of the QPPV
*Knowledge and application of change control to regulatory procedures
*Knowledge of EU regulatory framework
*Strong communication skills is essential

A salary range of €45,000 - €50,000 is on offer depending on level of experience. A minimum of three years experience in a similar regulatory affairs role is required. This is an exciting opportunity where gain significant experience and exposure to a range of products covering a variety of markets.
If you are interested in this position please contact me, Niamh Irwin, on for more information and immediate consideration. Interviews will be immediate with a decision made before Christmas if you are suitable for the role and available between now and then!

***If you know anyone who may be interested in working in Tipperary or this role please let me know*** Sthree UK is acting as an Employment Agency in relation to this vacancy.
Start date
12/2013
From
Real Staffing
Published at
18.12.2013
Project ID:
642338
Contract type
Permanent
To apply to this project you must log in.
Register