Senior Director, EU Regulatory Affairs – Oncology Strategy

Olema Oncology; Leinster; On-site; EUR 160,000 - 200,000; Full time

Job summary

Olema Oncology, a clinical-stage biopharmaceutical company based in Ireland, is seeking a Senior Director, EU Regulatory Affairs to lead the European regulatory affairs function for Olema International from Dublin. The role drives EU regulatory strategies, interactions with EMA and NCAs, and lifecycle management for oncology programs, with 15%–20% travel planned.

The ideal candidate has 15+ years in regulatory affairs, strong leadership, and a deep understanding of EU CTR/CTIS processes, MAAs,

Qualifications

• Advanced degree in Life Sciences, Pharmacy, Regulatory Science, or a related scientific discipline.
• Minimum of 15 years of progressive Regulatory Affairs experience within the biotechnology or pharmaceutical industry.
• 5+ years of direct leadership.
• Experience with EU CTR, CTIS, EMA centralized procedures, and interactions with National Competent Authorities.
• Oncology regulatory experience strongly preferred and experience leading MAAs and post-approval lifecycle management.

Responsibilities

• Serve as EU Authorized Representative for Olema International and ensure compliance with EU pharmaceutical regulations.
• Develop and execute EU regulatory strategies to support oncology development and lifecycle management.
• Lead European regulatory support for clinical development activities, including CTIS submissions and CTAs.
• Oversee MAA submissions and lifecycle management in collaboration with Global Regulatory Affairs.
• Act as regulatory liaison with EMA, NCAs, Ethics Committees and other authorities.
• Manage regulatory registrations, licenses, and compliance across the EU.
• Collaborate cross-functionally with Clinical Development, Quality, CMC, Pharmacovigilance, Legal, and Global Regulatory Affairs.
• Establish regulatory governance and inspection readiness.
• Represent Olema International with regulatory authorities and industry groups.

Skills

Regulatory leadership

Strategic regulatory planning

Cross-functional collaboration

Influencing stakeholders

Regulatory strategy

Education

Advanced degree in Life Sciences/Regulatory Science/Pharmacy

15+ years regulatory affairs in biotech/pharma

5+ years of leadership

Job description

Olema Oncology, a clinical-stage biopharmaceutical company based in Ireland, is seeking a Senior Director, EU Regulatory Affairs to lead the European regulatory affairs function for Olema International from Dublin. The role drives EU regulatory strategies, interactions with EMA and NCAs, and lifecycle management for oncology programs, with 15%–20% travel planned.

The ideal candidate has 15+ years in regulatory affairs, strong leadership, and a deep understanding of EU CTR/CTIS processes, MAAs,