Director of Regulatory Affairs

Job Summary

Providing strategic and operational leadership, the full-time remote Director of Regulatory Affairs will manage high-priority regulatory filings and submissions, ensuring alignment across various teams while supporting executive decision-making and enhancing program management capabilities.

Key responsibilities

• Partners with Regulatory Affairs and senior stakeholders to translate regulatory strategy into execution plans
• Leads the planning and execution of complex regulatory programs across multiple functions and products
• Identifies and communicates program risks and opportunities while providing actionable visibility into program status for senior leadership

Required qualifications

• Bachelor's degree with a minimum of 12 years of relevant regulatory project management experience, or a Master's degree with 10 years of experience, or a PhD/PharmD/DVM with 6+ years of experience
• Prior solid tumor oncology experience is required
• Significant experience leading complex, global regulatory programs and major submissions
• Strong understanding of pharmaceutical development and the regulatory submission lifecycle
• Proficiency in program management and planning tools such as MS Office and Project