Regulatory Affairs Officer

Job Listing No: 9740000

Regulatory Affairs Officer

Tina Dunne – Dublin – Regulatory Affairs Officer: Dublin City Centre Based PURPOSE We are currently recruiting for a Regulatory Affairs Officer to join a rapidly growing Global Regulatory Affairs team located in Dublin. Your role will be to prepare, contribute to and manage MAAs and Lifecycle activities for our current and actively growing range of pharmaceutical products, therapeutic indications and international markets. RESPONSIBILITIES Acts as responsible Regulatory Team member for assigned regulatory projects Preparation of submissions including Marketing Authorization Transfer, CMC variation filling, initial MAA filling, labelling updates, renewals, CMC authoring and or updates as required. Prepares and/or reviews regulatory documentation for DCP, MRP and National applications in line with assigned timelines. Actively participates and employs effective communication practices with internal customers (CMC, Supply Chain, Quality, Legal, Clinical, Pharmacovigilance, Regional Regulatory Manag… – Permanent – Full-time

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