EU Regulatory Affairs Leader — Senior Director

Olema Oncology; Dublin; On-site; EUR 180,000 - 230,000; Full time

Benefits offered by this job

Competitive compensation and benefits

Job summary

Olema Oncology seeks a Senior Director, EU Regulatory Affairs to lead the European regulatory strategy for Olema International, based in Ireland. This role directs EU submissions, interacts with EMA and NCAs, and guides lifecycle management of oncology programs.

15%–20% travel is expected, with strategic oversight across cross-functional teams in a fast-growing company. The ideal candidate will have 15+ years in Regulatory Affairs, strong leadership, and oncology regulatory experience, driving

Qualifications

• Minimum of 15 years of progressive Regulatory Affairs experience.
• 5+ years of direct leadership.
• Experience with EU CTR, CTIS, EMA centralized procedures and interactions with NCAs.
• Oncology regulatory experience strongly preferred.
• Ability to develop regulatory strategy and lead cross-functional initiatives in a global, matrixed organization.

Responsibilities

• Lead EU Regulatory Affairs for Olema International, the European subsidiary based in Ireland.
• Develop and execute EU regulatory strategies aligning with global objectives.
• Lead European regulatory support for clinical development activities (CTIS submissions, CTAs, modifications).
• Oversee MAA submission, approval, and lifecycle management.
• Serve as regulatory liaison with EMA, NCAs, Ethics Committees and other authorities.

Skills

Regulatory strategy & leadership

European regulatory affairs

Communication & influencing

Cross-functional collaboration

Regulatory documentation & submissions

Education

Advanced degree in Life Sciences/Pharmacy

Job description

Olema Oncology seeks a Senior Director, EU Regulatory Affairs to lead the European regulatory strategy for Olema International, based in Ireland. This role directs EU submissions, interacts with EMA and NCAs, and guides lifecycle management of oncology programs.

15%–20% travel is expected, with strategic oversight across cross-functional teams in a fast-growing company. The ideal candidate will have 15+ years in Regulatory Affairs, strong leadership, and oncology regulatory experience, driving