Director, Global Regulatory Project Management

Beonemedicines Com Au

$176,000.00 - $236,000.00 annually; bonus/equity: ...
Global regulatory strategies
Nda/bla/maa submissions
Cross-functional integration
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.
  • This role combines deep regulatory expertise with advanced project management and organizational leadership, driving successful NDA/BLA/MAA submissions and ensuring seamless cross-functional integration across regions.
  • The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

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

$176,000.00 - $236,000.00 annually; Bonus/Equity: Eligible for annual bonus plan (Non-Commercial) or incentive compensation plan (Commercial), discretionary equity awards, Employee Stock Purchase Plan; Benefits: Comprehensive benefits package

Skills & Requirements

Must-have

  • Global regulatory strategies
  • NDA/BLA/MAA submissions
  • Cross-functional integration
  • Regulatory environments and policy trends
  • Project management and document management tools
  • ICH, US, EU, China requirements

Nice-to-have

  • Scientific and business professionals
  • Highly motivated, collaborative
  • Passionate interest in fighting cancer
  • Proactive, not reactive
  • Integrity, accountability, strategic leadership
  • Fosters Teamwork
  • Analytical Thinking/Data Analysis

Key Requirements

  • Bachelor’s degree in Science or related discipline
  • Minimum 10+ years of experience
  • Experience leading cross-functional and cross-regional teams
  • PMP or similar certification preferred

Work Rights

Not specified

Tailored Resume

Cover Letter