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Details

Regulatory Affairs Manager


Reference:SC/HQ00001959 Location: Kerry
Qualification:DegreeExperience:4-5 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Regulatory Affairs Specialist, Regulatory Affairs Officer, Regulatory Affairs Manager, Regulatory Affairs Executive, Regulatory Affairs Consultant, Regulatory Affairs, Registration Officer

Regulatory Affairs Manager
Our client requires a Regulatory Affairs Manager to joint their team. The ideal candidate will have excellent experience in the area of EU filing for Part 2 dossiers and in FDACMC portion of licence application.

Responsibilities
• Project management for US applications to FDA for a NADA and to secure further marketing authorisations internationally
• Provide regulatory support for licensing activities in EU and non¬EU territories
• Auditing registration dossiers for the EU in order to evaluate and identify any
possible deficiencies prior to assessment
• Liaising with Regulatory Authorities and Affiliates
• Mentoring and daily oversight of Regulatory Affairs Officer
• Managing post -licensing activities (variations, renewals, etc.)

Requirements
• Life science , Pharmacy or Veterinary degree
• Minimum of 5 years EU pharmaceutical regulatory affairs industry experience
• Knowledge and prior experience in EU filing of Part 2 dossiers for Injectable sterile products is required
• Excellent attention to detail
• Highly organised, motivated and approachable team player


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

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