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.

The Person

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

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