Regulatory Affairs Officer

Job Listing No: 9740000

Regulatory Affairs Officer

CV-Library – Dublin – United Kingdom – Job title: Regulatory Affairs Officer Location: Dublin Reporting to: Regulatory Manager Liaises with: All relevant departments Principal Duties and Responsibilities: Ensure that all new license and variation applications are planned, tracked and obtained in a timely manner in accordance with various EU submission procedures. Preparation and submission of license and variations to the HPRA, MHRA and other Regulatory Authorities as required. Liaise directly with the regulatory authorities in order to ensure timely approvals and speedy resolution of any issues. Ensure all operations are fully compliant with license details and updated in accordance with relevant guidelines and directives. Ensure up to date files are maintained for all licensed products manufactured and/or released at Athlone. Review of relevant reports to ensure compliance with license details and relevant guidelines and directives. Review and approval of all new and revised master batch documentation, QC… – Permanent – Full-time

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