Senior Director, EU Regulatory Strategy

About the Role >>> Senior Director, EU Regulatory Affairs

Reporting to Senior Vice President, Regulatory Affairs, the Senior Director, EU Regulatory Affairs is responsible for leading the Regulatory Affairs function for Olema International, the Company's European subsidiary based in Ireland. Serving as the EU Authorized Representative, this individual provides strategic leadership for European regulatory activities supporting Olema's oncology programs and future commercialization efforts. The role is accountable for developing and executing EU regulatory strategies, leading interactions with the European Medicines Agency (EMA) and National Competent Authorities (NCAs), overseeing Clinical Trial Applications (CTAs) and CTIS activities, directing the submission and lifecycle management of the European Marketing Authorization Application (MAA), and ensuring ongoing regulatory compliance across the European Union.

This role is based out of our Dublin, Ireland office and will require 15% - 20% International travel.

Your work will primarily encompass:

• Serve as the EU Authorized Representative for Olema International, ensuring compliance with applicable European Union pharmaceutical legislation and regulatory requirements
• Develop and execute EU regulatory strategies that support oncology clinical development, marketing authorization, commercial readiness, and product lifecycle management while aligning with global regulatory objectives
• Lead European regulatory support for clinical development activities, including CTIS submissions, Clinical Trial Applications (CTAs), substantial modifications, notifications, and lifecycle management
• Provide strategic leadership for the preparation, submission, approval, and lifecycle management of the European Marketing Authorization Application (MAA), partnering with Global Regulatory Affairs and cross-functional teams
• Serve as the primary regulatory liaison with the EMA, National Competent Authorities, Ethics Committees, and other European regulatory authorities
• Oversee all regulatory registrations, authorizations, licenses, and corporate regulatory obligations required to support Olema International
• Partner cross-functionally with Clinical Development, Clinical Operations, Quality, CMC, Pharmacovigilance, Legal, and Global Regulatory Affairs to ensure compliance and support business objectives
• Establish and maintain regulatory governance, processes, and documentation to ensure inspection readiness and operational excellence
• Represent Olema International with regulatory authorities, industry organizations, and external stakeholders

Ideal Candidate Profile >>> European Union Regulatory Representative

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.

Education and Required Skills

• Advanced degree in Life Sciences, Pharmacy, Regulatory Science, or a related scientific discipline; advanced professional degree preferred
• 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
• Oncology regulatory experience is strongly preferred
• Experience leading successful European MAA submissions and approvals required
• Demonstrated ability to develop regulatory strategy, influence executive decision-making, and lead complex cross-functional initiatives in a global, matrixed organization

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