Regulatory Affairs Officer

This global pharma leader employs over 10,000 staff worldwide and operate an EU HQ in Dublin. They manufacture in over 25 operations at 18 sites on 6 continents and are a respected global supplier of branded and generic pharmaceutical products as well as infant nutritional and consumer healthcare products in selected territories. Additionally they boast a proud heritage dating back more than 160 years and are committed to sustaining life and promoting healthcare through increasing access to its high quality, effective, affordable medicines and products.

The Position

Our client are looking for a Regulatory Affairs Officer to join their Compliance team based in their EU headquarters in Dublin.

Your main responsibilities as Regulatory Officer will include:

  • Managing new applications, variations and maintenance of International MA’s
  • Supporting New Product Introductions Internationally
  • Gap analysis and remediation of International CMC documentation
  • Assisting with development of International regulatory strategy and regulatory intelligence and collaboration with stakeholders to support active MA’s and related activities
  • Performing assigned tasks right first time, in accordance with best practice and internal processes

The Person

You must possess the following to be considered for this Regulatory Affairs Officer role:

  • BSc in life science or pharmacy degree.
  • 1+ years’ experience working in a regulatory role .
  • Relevant experience working in the pharmaceutical industry.
  • Knowledge of EU and other regions current registration and dossier requirements.

To find out more apply online or call Aoife Byrne at HRM +353 1 6321866

Salary: On Application Location: Dublin West