Senior Regulatory Affairs Officer

Job Listing No: 9740000

Senior Regulatory Affairs Officer

Thornshaw Recruitment – Dublin – My client, a global pharmaceutical company with offices in Dublin City now have a new vacancy for a Senior Regulatory Affairs Officer. Your role is to provide regulatory affairs support and manage International MAAs and Lifecycle activities for their current and actively growing range of pharmaceutical products, CAMs, R&D pipeline products’ therapeutic indications and international markets. Promote and facilitate team and corporate growth and success. Key Responsibilities: Acts as responsible Regulatory Team member for assigned regulatory projects (medicinal products, and ad hoc R&D pipeline) Preparation and filing of submissions including life-cycle maintenance variations, initial MAA filling, labelling updates, renewals, obtaining CPPs, Marketing Authorisation Transfers (MATs) and publishing. Prepares and/or reviews regulatory documentation for DCP, MRP and National applications in line with assigned timelines. Support the strategic and operational planning and registration … – Permanent – Full-time

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