Director, Global Regulatory Project Management

beonemedicines.de

Base: $176,000.00 - $236,000.00 annually; bonus/eq...
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Global regulatory strategies
Nda/bla/maa submissions
Cross-functional integration
** BeOne Medicines is seeking a Director of Global Regulatory Project Management to lead oncology regulatory strategies and manage complex submissions across global markets. The ideal candidate will have significant experience in regulatory project management and a strong understanding of the drug development lifecycle, with a commitment to collaboration and innovation in fighting cancer. **

Job Summary

  • The Director, Global RPM 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.
  • 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

Match Score: 75

** BeOne Medicines is seeking a Director of Global Regulatory Project Management to lead oncology regulatory strategies and manage complex submissions across global markets. The ideal candidate will have significant experience in regulatory project management and a strong understanding of the drug development lifecycle, with a commitment to collaboration and innovation in fighting cancer. **

Salary

Base: $176,000.00 - $236,000.00 annually; Bonus/Equity: Eligible for annual bonus plan or incentive compensation plan, discretionary equity awards, and Employee Stock Purchase Plan; 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 project management
  • ICH, US, EU, China requirements

Nice-to-have

  • Scientific and business professionals
  • Collaborative and passionate interest
  • Proactive risk identification
  • Process optimization and improvement

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
  • PMP or similar certification preferred

Work Rights

Not specified

Tailored Resume

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