Regulatory Affairs Officer, Co. Meath

Leinster Appointments is currently recruiting for a permanent, full time Regulatory Affairs Officer in Co. Meath.

Permanent, full time role.

Hybrid - 2 days from home. For the first 4 months, it will be 1 day from home for training purposes.

Salary €50,000 - €80,000 and will depend on the candidates' experience.

• Ensuring the Company's products comply with all relevant regulations and standards
• Knowledge and execution of Type IA, IB and II Variations
• Licence transfers in various international territories
• Review of promotional material for medicinal products
• Preparation of Module 1 documentation for National Applications
• Prepare for and participate in meetings with Regulatory Authorities
• Deal with regulatory aspects of internationalising products and applying for reclassification of products
• Train and mentor more junior team members on Regulatory processes and compliance requirements
• Monitor and interpret regulatory trends and changes relevant to the industry and keep the Company appraised of these.

• Highly resilient and adaptable, able to work under pressure and within time constraints
• Drives results on a timely basis and sees things through to conclusion
• Knowledge of MRP, DCP, CP
• Knowledge of medical devices highly desirable
• Excellent attention to detail and organisational skills
• Capable of working on own initiative and taking responsibility for course of action
• 3-4 years previous experience essential