15h Left Senior Regulatory Affairs Officer Job In Dublin

A Senior Regulatory Affairs Officer is sought to provide regulatory support and manage international marketing authorizations for pharmaceutical products.

**Job Description** We are seeking a highly experienced Senior Regulatory Affairs Officer to join our team in Dublin. The successful candidate will provide regulatory affairs support and manage international marketing authorizations for our current and growing range of pharmaceutical products. **Key Responsibilities:** • Acts as a 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 filings, 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. • Actively participates in and employs 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.