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Details

Regulatory Affairs Graduate


Reference:AXOA-474126 Location: Kerry
Qualification:DegreeExperience:Graduate
Job Type:Temporary ContractSalary: Not Disclosed
May be suitable for: Graduate

Regulatory Affairs Graduate
Our client, a Kerry based veterinary pharmaceutical company, are currently recruiting for a Regulatory Affairs Graduate to join their team.
This initial one year contract position (with potential to become permanent thereafter) will report to the Regulatory Affairs Manager.

Responsibilities

  • Assist in the preparation of protocols and reports for studies for regulatory dossiers, by interpreting regulatory requirements in individual regions
  • Have particular responsibility for assembling Part 2 (Quality) section of EU dossiers, as well as the CMC portion of US FDA NADA applications for sterile injectable products
  • Provide regulatory support for license maintenance activities in EU and non-EU territories
  • Assist in securing further marketing authorisations internationally
  • Liaise with Regulatory Authorities and affiliates
  • Manage post-licensing activities (variations, renewals, etc.)


Requirements

  • Masters or Bachelors degree in Chemistry (preferred), Life Science or Pharmacy
  • Regulatory experience is preferred, however candidates with strong technical knowledge/analytical background may also be considered
  • Highly organised, motivated and approachable
  • Excellent attention to detail
  • Strong, dynamic team player but needs to also work well on own initiative
  • Comfortable with multi-tasking



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

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