Director, Global Regulatory Project Management

BeOne

Base: $176,000.00 - $236,000.00 annually; bonus/eq...
10+ years regulatory project management experience
Global submission leadership ind cta nda bla maa
Cross-regional stakeholder management us eu china
The Director serves as a principal advisor to the Global Regulatory Lead, translating strategic vision into actionable project plans for global product development

Job Summary

  • The Director serves as a principal advisor to the Global Regulatory Lead, translating strategic vision into actionable project plans for global product development.
  • This role requires managing complex regulatory submissions across multiple regions while ensuring seamless cross-functional integration and on-time delivery.
  • BeOne offers a comprehensive benefits package including medical, dental, vision, 401(k), and discretionary equity awards for all employees.

Matching Summary

The Director serves as a principal advisor to the Global Regulatory Lead, translating strategic vision into actionable project plans for global product development.

Salary

Base: $176,000.00 - $236,000.00 annually; Bonus/Equity: Eligible for annual bonus plan and discretionary equity awards; Benefits: Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, Wellness

Skills & Requirements

Must-have

  • 10+ years regulatory project management experience
  • Global submission leadership IND CTA NDA BLA MAA
  • Cross-regional stakeholder management US EU China
  • ICH and international regulatory compliance expertise
  • Smartsheets MS Project Power BI proficiency

Nice-to-have

  • PMP or similar certification preferred
  • Advanced degree in Science or related field
  • Experience with biologics and small molecules
  • Proactive problem-solving and conflict resolution
  • Mentoring junior staff and fostering culture

Key Requirements

  • Bachelor's degree in Science; advanced degree preferred
  • Minimum 10+ years in regulatory project management
  • Demonstrated success in global NDA/BLA/MAA submissions
  • Experience leading cross-functional and cross-regional teams

Work Rights

Not specified

Tailored Resume

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