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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Regulatory Affairs Officer


Reference:SCAXOA-474126 Location: Kerry
Republic of Ireland
Qualification:DegreeExperience:1-2 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Regulatory Affairs, Regulatory Affairs Executive, Regulatory Affairs Officer

Regulatory Affairs Officer
Our client, an animal health company based in Kerry are currently recruiting for a Regulatory Affairs Officer to join their team. This is a super opportunity for a candidate with 1-2 years’ experience in Regulatory affairs to gain more in-depth exposure to Regulatory Affairs. Our clients offices will be based in Killarney, Co. Kerry and you will be required to be on site for this role.

Responsibilities

  • Project manage marketing authorization applications internationally, dossier preparations and be responsible for regulatory filing
  • Project manage product life cycle regulatory issues including post marketing authorisation variations, amendments, renewals, etc. and all associated technical pharmaceutical studies
  • Regulatory team member part of project teams for new product development
  • Responsible for the maintenance and filing of patents & patent renewals in EU, USA and internationally. Role includes co-ordinating appropriate studies to support patents & formulations development
  • In conjunction with existing staff, support the preparation of dossier files for marketing authorisations including Part 1/Admin sections & Part 2 CMC pharmaceutical sections
  • In conjunction with the quality team, provide technical and regulatory input to quality & QA for documentation associated with existing product manufacture
  • Liaise as needed with CMO's on regulatory matters, change controls, regulatory filing matters including studies for new licences or variations, change controls, and audits for regulatory compliance
Requirements
  • BSc Ideally Chemistry, or related discipline
  • 1- 2 years’ experience in pharmaceutical industry
For more information contact Sinéad Cullen on +35387950082 or [email protected]