The Director, Global Regulatory Project Management is a senior strategic leader responsible for supporting, influencing, translating, and executing oncology regulatory strategies across the global drug development lifecycle
Job Summary
The Director, Global Regulatory Project Management is a senior strategic leader responsible for supporting, influencing, translating, and executing oncology regulatory strategies across the global drug development lifecycle.
Lead and manage complex regulatory submissions (IND/CTA, NDA/BLA/MAA) across multiple regions, ensuring compliance with ICH, US, EU, China, and other international requirements.
Build partnerships with senior stakeholders and cross-functional teams (clinical, medical, safety, CMC, commercial) across regions to achieve strategic business goals through knowledge sharing and collaboration.
Matching Summary
The Director, Global Regulatory Project Management is a senior strategic leader responsible for supporting, influencing, translating, and executing oncology regulatory strategies across the global drug development lifecycle.
Salary
Base: $176,000.00 - $236,000.00 annually; Bonus/Equity: Eligible for annual bonus plan and discretionary equity awards; Benefits: Comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness
Skills & Requirements
Must-have
Global regulatory strategies
NDA/BLA/MAA submissions
Cross-functional integration
Regulatory environments awareness
ICH, US, EU, China requirements
Cross-regional collaboration
Nice-to-have
Scientific and business professionals
Highly motivated, collaborative
Passionate interest in fighting cancer
Proactive, not reactive
Integrity, accountability, strategic leadership
Key Requirements
Bachelor’s degree in Science or related discipline
10+ years of experience in regulatory project management
Experience leading cross-functional and cross-regional teams