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.

The Role

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

The Person

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?

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: €40000 - €55000 Location: Tipperary