Regulatory Affairs Senior Director - Global Regulatory Leader - Oncology

📋 Description

• Lead Global Regulatory Teams for late-stage oncology programs with global complexity.
• Develop and execute global regulatory strategies for development, registration, labeling, and
• Represent Regulatory Affairs on product teams and governance bodies to influence decisions.
• Develop Global Regulatory Strategic Plans with cross-functional input.
• Identify and mitigate regulatory risks across development and commercialization.
• Lead global regulatory submissions and ensure consistency with strategy.

🎯 Requirements

• Doctorate with 5+ years regulatory biotech experience or Master’s with 9+ years or Bachelor’s with
• 5+ years of direct people leadership/management experience.
• Experience leading regulatory strategy for highly complex late-stage programs.
• Oncology regulatory experience strongly preferred.
• Proven success in regulatory submissions and agency interactions.
• Strong communication, leadership, and cross-functional collaboration skills.

🎁 Benefits

• Annual U.S. base salary range of $215,204.70–$291,159.30, determined by skills/experience.
• Comprehensive health and welfare benefits, including medical, dental, vision.
• Retirement plan with company contributions; life and disability insurance.
• Flexible spending accounts and discretionary bonus.
• Stock-based long-term incentives and paid time-off programs.
• Career development and inclusive, collaborative culture.