RA Officer

An esteemed pharmaceutical group are seeking to appoint a Regulatory Affairs professional to join their Dublin operation. This organisation’s primary driver is the development and commercialisation of speciality products and other high-value niche products with novel products under commercialisation at present, that will be added to their impressive product portfolio.

The Role

Reporting directly into the Associate Director of Regulatory Affairs, you will ensure all new and post licence submissions are planned, tracked and submitted in a timely fashion. You will be liaising directly with regulatory authorities to ensure timely approvals and rectify any issues that may arise.

You will also be responsible for:

  • Collaborating across functions to fulfil preparation and assembly of submissions, review and approval of scientific literature
  • Coordinating meetings with global and regional cross functional teams to discuss and resolve issues
  • Auditing registration dossiers to ensure regulatory compliance
  • Managing and maintaining regulatory databases
  • Identifying, authoring, reviewing and approving regulatory SOP’s

The Person

To be a successful appointee, you will need to possess the following:

  • Life science/pharmacy degree or equivalent accompanied with relevant industry experience
  • 3+ years’ Regulatory Affairs experience within the Pharmaceutical sector
  • Eligible to live and work in the EU
  • Previous exposure to dossiers and European Regulatory experience e.g. National, MRP, DCP is an advantage

To find out more apply online or contact Sorcha Hayward directly on +353 1 6321866 for a confidential discussion

Salary: €40000 - €40000 Location: Dublin South