Director of Regulatory Affairs (Europe) – Hybrid, Ireland-BasedLocation:IrelandPosition Type:Full-Time, Hybrid – 3 days/week onsiteOverviewOur client is a leading Rare Disease biopharmaceutical company committed to advancing innovative treatments to improve patient outcomes. Their mission is to transform care by delivering cutting-edge therapies while fostering strong scientific engagement with healthcare professionals and researchers.Our client is seeking a highly experiencedDirector of Regulatory Affairs (Europe)to lead the company's regulatory strategy and execution across European markets. This is a key leadership role responsible for guiding products through clinical development, marketing authorization, and lifecycle management, while serving as the primary regulatory interface with EMA and national competent authorities.Key ResponsibilitiesLead development and execution of European regulatory strategy in alignment with global objectives.Oversee preparation, submission, and maintenance of regulatory dossiers (e.g., MAAs, variations, renewals) to ensure timely approvals.Serve as the primary liaison with EMA and national health authorities, managing communications, negotiations, and regulatory interactions.Provide regulatory leadership and guidance during product development, registration, and post-market activities.Ensure compliance with EU regulatory requirements, including applicable directives (e.g., 2001/83/EC) and guidelines (EMA, ICH, GxP).Monitor evolving EU regulatory frameworks, assess business impact, and advise executive leadership.Partner with cross-functional teams (R&D, Clinical, Medical, Quality, Legal, and Commercial) to ensure regulatory alignment and launch readiness.Represent Regulatory Affairs on European leadership teams and in global regulatory forums.Support organizational growth by mentoring and developing regulatory staff and establishing KPIs for performance and compliance.Contribute to global regulatory policy, SOP development, and best practices.Qualifications & ExperienceMinimum of 15 years of progressive experience in Regulatory Affairs within the biopharmaceutical industry, ideally in rare/orphan diseases.Proven track record of leadership in regulatory strategy, submissions, and health authority interactions in Europe.In-depth knowledge of EMA and EU regulatory frameworks, including centralized and decentralized procedures.Demonstrated success leading regulatory activities from development through commercial launch.Strong experience working in dynamic, cross-functional, and international environments.Exceptional communication, negotiation, and collaboration skills, with ability to influence senior stakeholders.Fluent in English; additional European language(s) a plus.Bachelor's, Master's, or PhD in Life Sciences, Pharmacy, or a related field (advanced degree preferred).