Senior Regulatory Affairs Director - Oncology

Role Summary

Senior Regulatory Affairs Director – Oncology, responsible for developing and implementing the global regulatory strategy for complex oncology programs with multiple indications, potentially serving as regional lead based on location. Leads external relationships with key stakeholders and acts as a senior leader within Regulatory Affairs.

Responsibilities

• Lead a Global Regulatory Strategy Team (GRST) of GRLs within the franchise, including contributions from regions, emerging markets, RA CMC, Labelling, and submission/execution teams.
• Craft and deliver a strategy that achieves approvals with competitive labeling aligned to product properties and business/patient needs.
• Assess emerging data against objectives and brief Leadership on risks and mitigations.
• Represent Regulatory Affairs on Global Product Teams, providing strategic regulatory advice and owning regulatory activities.
• Own delivery of milestones, evaluating regulatory success probabilities via risk/mitigation analyses.
• Demonstrate strategic leadership to contribute to effective product development.
• Promote novel regulatory initiatives, engage externally on relevant topics, and lead development of new tools/technology.
• Partner and influence global views/guidance.

Qualifications

• Essential: An advanced degree in a science-related field or equivalent knowledge/experience.
• Regulatory drug development experience including product approval/launch; leadership of at least one major global regulatory approval with leading response teams and labeling negotiations (desired).
• Experience leading major health authority interactions.
• Solid knowledge of regulatory affairs across multiple therapeutic areas in early and late development.
• Broad pharmaceutical business experience with regulatory affairs; experience in small molecules and biologics preferred.
• Proven leadership experience; ability to think strategically and critically and evaluate regulatory risks.
• Deep understanding of global regulatory science and drug/biologic development processes for high-profile or novel programs.

Desirable

• Experience with radio-conjugates.
• Experience with FDA advisory committees and EMA oral explanations.
• Experience with due diligence and business alliances.
• Ability to operate strategically within complex, high-profile development programs.