Regulatory Affairs Specialist – Tipperary

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 Regulatory Affairs professional to the team in Tipperary.

The Role:

Reporting to the director of Regulatory affairs 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.

The Person

In order to qualify for the role you must possess the following to be considered:

  • A BSc in Science or related.
  • 2+ 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.

The Benefits:

  • Excellent Training
  • Competitive salary
  • Healthcare
  • Pension

To find out more apply online or call Gillian McMurrough directly on +353 1 6321827 to have a confidential discussion.

Salary: €50000 - €65000 Location: Tipperary