Senior Regulatory Affairs Officer Job In Dublin

**Senior Regulatory Affairs Officer** A highly skilled professional is sought to provide regulatory affairs support and manage international marketing authorizations and lifecycle activities for a global pharmaceutical company's range of pharmaceutical products.

**Key Responsibilities:** • Acts as responsible Regulatory Team member for assigned regulatory projects, including medicinal products and R&D pipeline. • Prepares and files submissions, including life-cycle maintenance variations, initial marketing authorization filing, labeling updates, renewals, and obtaining certificates. • Prepares and/or reviews regulatory documentation for DCP, MRP, and national applications in line with assigned timelines. • Supports the strategic and operational planning and registration of combination products in global markets. • Participates in effective communication practices with internal customers, including CMC, CAMs team, Supply Chain, Quality, Legal, Clinical, Medical, Pharmacovigilance, and globally based Regulatory Managers.

**Requirements:** • Life science related degree and 5 years of pharmaceutical regulatory experience, focusing on lifecycle maintenance of marketed products in Europe and/or emerging markets. • Positive and proactive approach and attitude to business tasks. • Ability to lead and support several concurrent projects/products and develop strong relationships within cross-functional teams. • Experience of emerging markets/international ROW markets and regulatory filings. • Quality control review of technical/regulatory documents. • Understanding of regulatory strategy and determination of documentation requirements compliance with SOPs, change controls, and regulatory best practices.