Director / Senior Director, Regulatory Affairs – EuropeIreland or EU (onsite presence required, hybrid flexibility)Therapeutic Area: Rare DiseasesWe are supporting afast-growing biopharmaceutical companydeveloping transformative therapies forrare diseases. With an established global operations and expanding European presence, the company is preparing for a pivotal stage in its growth and is now seeking aRegulatory Affairs leader for Europe.This is a unique opportunity to step into asenior leadership rolewhere you will:Lead regulatory strategy and execution across all EU markets.Act as the primary interface with EMA and national competent authorities .Oversee submissions including MAAs, variations, and renewals .Shape and align regional strategies with global business objectives .Partner with Clinical, Medical, and Commercial teams to guide programs in rareRepresent Europe on global regulatory leadership teams.We're looking for someone who brings: 15+ years of regulatory affairs experience in biopharma. Proven leadership inEMA procedures(centralised and decentralised). Hands-on experience withrare disease. Strong track record inagency interactions and negotiations. Strategic vision, collaborative mindset, and the ability to influence at the executive level.This is a chance tomake a direct impact on patients living with rare diseases, while leading regulatory affairs for Europe at a critical time of growth.If you are interested in exploring this opportunity, please reach out directly to a.- for a confidential chat.