Senior Director, EU Regulatory Strategy
On-siteDublin, Leinster, Ireland
Dublin, Leinster, IrelandOn-siteFull TimeSenior LevelBiopharmaceuticalSmall
Full TimeSenior LevelSmallBiopharmaceutical
Job Summary
Lead EU regulatory strategy for Olema International's oncology programs, serving as the EU Authorized Representative and managing interactions with the EMA and National Competent Authorities. Oversee Clinical Trial Applications, CTIS submissions, and the lifecycle management of the European Marketing Authorization Application while ensuring full compliance with EU pharmaceutical legislation. Partner cross-functionally with Clinical Development, Quality, and Global Regulatory Affairs to drive commercial readiness and maintain inspection readiness. This role requires 15-20% international travel and is based in Dublin, Ireland.
Required Qualifications
- Advanced degree in Life Sciences, Pharmacy, Regulatory Science, or a related scientific discipline
- Advanced professional degree
- Minimum of 15 years of progressive Regulatory Affairs experience within the biotechnology or pharmaceutical industry
- 5+ years of direct leadership
- Effective communicator with executive presence and influencing skills
- Sound judgment and decision-making in complex, risk-based environments
- Demonstrated expertise in European regulatory affairs, including the EU Clinical Trials Regulation (CTR), CTIS, EMA centralized procedures, and interactions with National Competent Authorities
- Significant experience leading or contributing to European Marketing Authorization Applications (MAAs) and post-approval lifecycle management
- Experience serving as, or supporting, the regulatory responsibilities of an EU legal entity, including regulatory compliance and licensing activities
- Experience leading successful European MAA submissions and approvals
- Demonstrated ability to develop regulatory strategy, influence executive decision-making, and lead complex cross-functional initiatives in a global, matrixed organization
Desired Qualifications
- Oncology regulatory experience
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