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Regulatory Affairs Site Officer

Regulatory Affairs Site Officer required for a leading biopharmaceutical organisation in the South East. The Regulatory Affairs Site Officer will work with the Site Regulatory team in support of product registrations and dossier management.

Overview of Main Responsibilities (full job description available on request):

  • Have in-depth knowledge with regard to CMC Regulatory aspects of specific products (commercial and/or clinical).

  • You will support product evaluations / changes with regard to regulatory assessment and product transfers.

  • Collaborate with local and Global (Development, Technical, Regulatory, Operational and Quality) stakeholders with regard to New Product Introduction – clinical supply, BLA submission, etc.

  • As a member of the team you will performs troubleshooting, (cross functional-) investigations, continuous improvements, formal and informal regulatory risk assessments.

What the ideal candidate looks like:

  • Minimum degree in Science. Ideal – MSc or PhD in a relevant discipline.

  • Significant experience in Regulatory CMC role in the pharma or biopharma sector.

What you will get in return:

  • Competitive Salary (depending on experience).

  • Flexible benefits

  • Subsidised restaurant

  • Onsite gym

  • Parking

For a confidential discussion and more information on the role, please contact Aisling Lane.

aisling.lane@collinsmcnicholas.ie

(021) 4320675