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Regulatory Affairs Specialist

I am currently recruiting for a driven Regulatory Affairs Specialist to join a team in Dublin within one of Ireland's largest Pharmaceutical companies who has a great market reputation. Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Specialist will be responsible for ensuring that the company comply with all of the regulations and laws pertaining to the Business and, maintaining the company's product registrations.

What you will be doing in the role:

  • Prepare regulatory strategies and contribute to business decision making in relation to product launches and product changes.
  • Manage responses to the heath authority questions and commitments.
  • Ensure that the organization documents are uploaded in the document management system according to quality standards.
  • Manage and oversee the Regulatory Submission Pipeline for cycle submission activities.
  • Manage performance on the Regulatory Submission Plans.
  • Participate in projects management.

What you will need:

  • Minimum BSc. in a Scientific related discipline.
  • 2+ years' experience in Regulatory Affairs in the Pharmaceutical, Biopharmaceutical or Medical Device organization.

The Next Step for you...

Should this position be of interest to you please forward your CV to Camila Ignacio from Next Generation Recruitment or alternatively call on the main line on +353 1 960 9773.

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