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Sinead Cullen
Life Science

01 507 9252
sinead.cullen@lifescience.ie
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Details

Senior Regulatory Affairs Specialist


Reference:AVKB-027411 Location: Kerry
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Regulatory Affairs, Regulatory Affairs Executive, Regulatory Affairs Officer, Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist
Our client, an Irish based organisation are currently recruiting for a Senior Regulatory Affairs Specialist to join their team on a permanent basis. There is opportunity for remote working after some time in the role. Reporting to the Regulatory Affairs Manager of Warburton Technology,

Responsibilities
• Ensure compliance to all relevant regulations and should have knowledge and experience of filing EU Part 2 Quality dossiers for Injectable sterile products, as well as the ability to project manage the CMC portion of a US FDA NADA application.
• Work with good initiative, be a dynamic team player and be comfortable with multi-tasking

Requirements
• Master’s or Bachelor’s degree in Science
• Regulatory experience is preferred, however, candidates with strong technical knowledge/analytical background may also be considered
• Be a strong team player but can also work well on own initiative

If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252