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RA Officer

Job Title: RA Officer
Contract Type: Permanent
Location: Tipperary
REF: 83211
Job Published: over 2 years ago

Job Description

RA Officer

Our client, a leading Pharmaceutical organisation, are currently recruiting for an RA Officer to join their team in Tipperary on a permanent basis.

Job Purpose:
The ideal candidate will have a life science or pharmacy background and a sound knowledge of European submission procedures and electronic applications (both NeeS and eCTD).

  • Management of a specific portfolio of products
  • Submission of new MAAs (abridged) in the EU via national, MRP and 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 internal departments and external parties to generate supporting data for submissions
  • Reviewing documentation to ensure compliance with MA details and relevant guidelines and Directives

  • Bachelor?s Degree in Science or related discipline
  • 2-3 years? experience within a similar role
  • Understanding of pharmacovigilance and the role of the QPPV
  • Knowledge and application of change control to regulatory procedures
  • Knowledge and understanding of the EU regulatory framework

For further information on this RA Officer role in Tipperary please contact Nicola O?Connell on 091730022 /
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