Director of Regulatory Affairs

4 weeks ago

Dublin, Dublin City, Ireland Morgan Prestwich - Life Science & Healthcare Executive Search Full time
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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