Senior Regulatory Affairs Professional
This Global pharmaceutical group are dedicated to the successful registration and launch of pharmaceutical products throughout the EU, South Africa, Australia, New Zealand and MENA territories with a team focused on maximising the commercial potential of pharmaceutical products. Operating across 3 sites: a solid dose manufacturing and packaging facility in Dublin, a Regulatory Affairs and Pharmacovigilance office located in Tipperary and a commercial office in the UK (Global HQ for the business). This company are part of one of the largest Pharmaceutical companies worldwide and due to continued growth are looking to add a Senior Regulatory Affairs professional to the team in Tipperary.
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 to be considered:
- A BSc in Science or related.
- 3-5+ years industry experience within a Regulatory Affairs function within the Pharma sector.
- 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: On Application