Regulatory Affairs Officer EU markets 2 roles

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This project has been archived and is not accepting more applications.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

Keywords

Description

Regulatory Affairs Officer -Tipperary

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:
*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:
*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

There are two positions available with salary ranging between €35,000 and €45,000 and €45,000 - €50,000 depending on level of experience. 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 Adele Moran on for more information and immediate consideration. Interviews will be immediate and they are ideally looking for people to start in September / October

To find out more about Real please visit www.realstaffing.com
Start date
06/2013
From
Real Staffing
Published at
16.08.2013
Project ID:
584093
Contract type
Permanent
To apply to this project you must log in.
Register