Role: Senior Regulatory Affairs Officer
Location: Office: Suite 12, Bunkilla Plaza, Bracetown Business Park, Co. Meath, Ireland
This is a great opportunity to join a pharmaceutical group which is enjoying significant growth both in Ireland/UK and internationally. Our group of companies are proud of our expanding business which includes market leading brands across OTC and Prescription medicines.
Due to this continued growth, we are now recruiting for this new position which will report into the Regulatory Affairs Manager.
Key responsibilities:
- 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.
Knowledge & Experience:
· 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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