Senior Regulatory Affairs Role – Munster
This Global pharmaceutical company employ a highly experienced international team focused on maximising the commercial potential of pharmaceutical products across Europe and other territories.
They boast a solid dose manufacturing and packaging facility in Dublin, a regulatory affairs office located in Tipperary and a commercial office in the UK.
Reporting to the director of Regulatory affairs, as the new Senior Regulatory Affairs professional, you will have responsibility across the following:
- 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 authorities
- 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
In order to qualify for the role you must possess the following in order to be considered:
- A BSc in Science or related
- 2+ years Industry experience within a Regulatory Affairs function
- Knowledge of European submission procedures and electronic applications (both NeeS and eCTD)
- Eligible to work within EU?
- Excellent Training
- Competitive salary
To find out more apply online or call Gillian McMurrough directly on +353 1 6321827 to have a confidential discussion.
Salary: €40000 - €55000