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Regulatory Site Officer

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Munster
  • Sector: Science
  • Date posted: 28/03/2018
  • Job reference: J384054A

Regulatory Site Officer

Job Overview

The Regulatory Site Officer will be both a technical and a product CMC expert and will work with the Site Regulatory team in support of product registrations and dossier management. You will have an unique opportunity to work with clinical development teams as well as involvement with new biologic product transfers and combination product launches.

Responsibilities:

  • Must demonstrate wide Regulatory business and awareness of lab / Manufacturing operations across several platforms and demonstrate ability to act with wider business context in mind;
  • Management of Regulatory aspects of product portfolio including CMC updates, Annual Reviews, New Product introductions, etc;
  • Key player in Product and Global Regulatory strategy;
  • Performs troubleshooting, (cross functional-) investigations, continuous improvements, formal and informal regulatory risk assessments.

Requirements & Qualifications:

  • Minimum degree in Science. Ideal - MSc or PhD in a relevant discipline;
  • Minimum of 3 years' experience in Regulatory CMC role in the pharma or biopharma sector.

For more information on this and similar opportunities please contact Kathryn on 016544520 or Email