Senior Director, EU Regulatory Strategy (Oncology)

Location: Dublin, Ireland office; requires 15%–20% international travel.

Company

hirify.global is a clinical-stage biopharmaceutical company developing therapies for breast cancer and other oncology indications, including palazestrant and OP-3136.

What you will do

• Serve as the EU Authorized Representative for Olema International and ensure compliance with European Union pharmaceutical legislation.
• Develop and execute EU regulatory strategies for oncology clinical development, marketing authorization, commercial readiness, and product lifecycle management.
• Lead CTIS submissions, Clinical Trial Applications, substantial modifications, notifications, and related lifecycle activities.
• Direct the preparation, submission, approval, and lifecycle management of European Marketing Authorization Applications.
• Act as the primary regulatory liaison with the EMA, National Competent Authorities, Ethics Committees, and other European authorities.
• Partner with Clinical Development, Clinical Operations, Quality, CMC, Pharmacovigilance, Legal, and Global Regulatory Affairs while maintaining governance, documentation, and inspection readiness.

Requirements

• Advanced degree in Life Sciences, Pharmacy, Regulatory Science, or a related scientific discipline; an advanced professional degree is preferred.
• At least 15 years of progressive Regulatory Affairs experience in the biotechnology or pharmaceutical industry.
• At least 5 years of direct leadership experience, with executive communication, influencing, judgment, and decision-making skills.
• Demonstrated expertise in European regulatory affairs, including the EU Clinical Trials Regulation, CTIS, EMA centralized procedures, and National Competent Authority interactions.
• Significant experience leading or contributing to European MAA submissions, approvals, and post-approval lifecycle management.
• Experience supporting the regulatory responsibilities, compliance, licensing, and corporate obligations of an EU legal entity; oncology regulatory experience is strongly preferred.

Culture & Benefits

• Work in a clinical-stage oncology company approaching its first potential commercial launch.
• Join a team focused on improving outcomes for patients with metastatic breast cancer and beyond.
• Work in a pragmatic, agile, and collaborative environment that values adaptability, learning, and excellence.
• Competitive compensation and benefits package.
• Open, flexible, and friendly work environment with opportunities for long-term career development.