Director, Global Regulatory Project Management

BeiGene

Base: $176,000.00 - $236,000.00 annually; bonus/eq...
10+ years regulatory project management experience
Global submission leadership (nda/bla/maa)
Oncology drug development lifecycle expertise
The Director serves as a strategic leader responsible for executing global regulatory strategies across the entire oncology drug development lifecycle

Job Summary

  • The Director serves as a strategic leader responsible for executing global regulatory strategies across the entire oncology drug development lifecycle.
  • This role acts as the COO to the Global Regulatory Lead, translating vision into actionable plans to ensure on-time submissions in multiple regions.
  • BeOne offers competitive compensation including base salary, annual bonus eligibility, discretionary equity awards, and a comprehensive benefits package.

Matching Summary

The Director serves as a strategic leader responsible for executing global regulatory strategies across the entire oncology drug development lifecycle.

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, and Wellness

Skills & Requirements

Must-have

  • 10+ years regulatory project management experience
  • Global submission leadership (NDA/BLA/MAA)
  • Oncology drug development lifecycle expertise
  • Cross-regional stakeholder management skills
  • ICH and international regulatory compliance knowledge

Nice-to-have

  • PMP or similar project management certification
  • Experience with Smartsheets and MS Project tools
  • Mentoring and developing junior staff capabilities
  • Strong negotiation skills with regulatory authorities
  • Proactive risk identification and resolution mindset

Key Requirements

  • Bachelor's degree in Science; advanced degree preferred
  • Minimum 10+ years of experience in regulatory submissions
  • Demonstrated success in global regulatory project management
  • Experience with both small molecules and biologics
  • Ability to lead cross-functional teams globally

Work Rights

Not specified

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