Description
Due to their continued expansion my client, a pharmaceutical company based in Co. Tipperary, is urgently recruiting a Senior Regulatory Affairs Officer to join their growing team. The ideal candidate will have a sound knowledge of European submission procedures and electronic applications (both NeeS and eCTD) and is a great opportunity for someone who is looking to grow and expand their career!Key Knowledge and Responsibilities:
- 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
- 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
Experience:
- A Bachelors Degree in a scientific discipline.
- A minimum of 3 years experience working in a similar regulatory affairs role.
A salary range of between €45,000 and €50,000 is on offer, depending on level of experience. This is an exciting opportunity where you can gain significant experience and exposure to a range of products covering a variety of markets. Interviews will be immediate!
If you are interested in this position please contact me, Niamh Irwin, on for more information and immediate consideration.
Sthree UK is acting as an Employment Agency in relation to this vacancy.