Overview
Our 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 experienced Director 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 Responsibilities
* Lead 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 & Experience
* Minimum 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).
Employment details
* Location: Ireland
* Position Type: Full-Time, Hybrid – 3 days/week onsite
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