Regulatory Affairs Officer
Thornshaw Recruitment – Dublin – On behalf of my client, a global pharmaceutical company based in Dublin City. I am currently recruiting for a Regulatory Affairs Officer. RESPONSIBILITIES Preparation and submittal of Life-Cycle Maintenance regulatory submissions for EU and global markets Prepares and/or reviews regulatory documentation for DCP, MRP and National applications in line with assigned timelines. May support on some R&D regulatory projects Actively participates and employs effective communication practices with internal customers (CMC, Supply Chain, Quality, Legal, Clinical, Medical, Pharmacovigilance, Globally based Regulatory Managers). Prepare status reports and metrics for assigned projects Perform assigned work according to current best good regulatory practice and in compliance with current legislation and regulatory guidelines at all times. REQUIREMENTS Degree in Pharmacy or life science-related degree Minimum 2 years pharmaceutical regulatory experience, focusing on lifecycle maintena… – Permanent – Full-time
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