10+ years regulatory project management experience
Global regulatory submission leadership
Oncology drug development lifecycle expertise
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 deep expertise in managing complex regulatory submissions across multiple regions including the US, EU, China, and APAC while ensuring timely market access.
BeOne Medicines offers a competitive salary range of $176,000 to $236,000 annually along with comprehensive benefits including medical, dental, vision, and equity awards.
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, and Wellness
Skills & Requirements
Must-have
10+ years regulatory project management experience
Global regulatory submission leadership
Oncology drug development lifecycle expertise
Cross-regional stakeholder management
ICH and international regulatory compliance
Nice-to-have
PMP or similar certification preferred
Experience with biologics and small molecules
Mentoring junior and mid-level staff
Process optimization and continuous improvement
Advanced proficiency in Smartsheets and Power BI
Key Requirements
Bachelor's degree in Science; advanced degree preferred
Minimum 10+ years in regulatory project management
Proven track record of successful global submissions
Strong business acumen and strategic thinking skills
Excellent verbal and written communication abilities