Regulatory Affairs Senior

Tipperary  ‐ Onsite
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Keywords

Description

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
* Strong communication skills is essential

There is an excellent salary of €40,000 - €50,000 plus pension and health benefits is on offer 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 Emmett Ryan on for more information and immediate consideration. Interviews will be immediate.

To find out more about Real please visit www.realstaffing.com
Start date
10/2013
From
Real Staffing
Published at
27.09.2013
Project ID:
604313
Contract type
Permanent
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