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

• BSc Ideally Chemistry, or related discipline
• 1- 2 years’ experience in pharmaceutical industry