You are visiting this website from:
View All Jobs

Regulatory Affairs Specialist

Job Seekers Ireland Science Life Science

Job Summary

  • Waterford
  • Permanent
  • BBBH791389
  • Aug 26, 2021
  • Competitive
Job Description

Excellent opportunity for an experienced Regulatory Affairs Specialist to join a global pharmaceutical company based in Waterford

Excellent opportunity for an experienced Regulatory Affairs Specialist to join a global pharmaceutical company based in Waterford

In partnership with our client, a multinational pharmaceutical company based in Waterford we are now hiring a Regulatory Affairs Specialist.

As the RA Specialist you will be both technical and product expert and will work with the Site Regulatory team in support of product registrations and dossier management while paying a part in supporting Site strategies.

Key responsibilities:

  • Liaising with QC/Project and Validation departments
  • Batch release and generation of annual product quality reviews
  • Have in-depth knowledge with regard to CMC Regulatory aspects of specific products (commercial and / or clinical).
  • Timely compilation and management of all necessary documentation for regulatory submissions.
  • Coordinate and track regulatory commitments related to the site.
  • 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 perform troubleshooting, (cross functional-) investigations, continuous improvements, formal and informal regulatory risk assessments.

Qualifications/ Education

  • Minimum degree in Science. Ideal - MSc or PhD in a relevant discipline.
  • Significant experience in Regulatory CMC role in the pharma or biopharma sector.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

broadbean-tracking

Consultant Details

Consultant Details

Ailis Dwyer
Ailis Dwyer
  • Consultant | Engineering Recruitment
  • 353 (0) 21 2300300
  • adwyer@morganmckinley.com