Oncology Regulatory Affairs Director

Job Summary

Leading global regulatory strategies, the full-time Regulatory Affairs Director will manage oncology development programs, serve as the representative on Global Project Teams, and drive regulatory submissions in a remote capacity.

Key responsibilities

• Lead global regulatory strategies and execution for assigned oncology development programs
• Serve as the Regulatory Affairs representative on Global Project Teams and lead the Global Regulatory Sub-Team (GRST)
• Drive regulatory submissions from planning through approval while ensuring high-quality deliverables

Required qualifications

• Advanced degree required
• 6+ years of Regulatory Affairs experience
• 3+ years of recent Oncology Regulatory experience
• Experience developing global regulatory strategies and leading regulatory submissions
• Successful Health Authority interactions with FDA and/or EMA