The Director will serve as a strategic leader responsible for translating global regulatory strategies into actionable project plans for oncology products
Job Summary
The Director will serve as a strategic leader responsible for translating global regulatory strategies into actionable project plans for oncology products.
This role acts as the COO to the Global Regulatory Lead, ensuring seamless cross-functional integration and on-time submissions across all major regions.
BeOne offers a comprehensive benefits package including medical, dental, vision, 401(k), and discretionary equity awards for all employees.
Matching Summary
The Director will serve as a strategic leader responsible for translating global regulatory strategies into actionable project plans for oncology products.
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
Global regulatory submission experience
Oncology drug development lifecycle
Cross-functional team leadership
ICH and regional regulatory compliance
Project management tools proficiency
Nice-to-have
PMP or similar certification preferred
Mentoring junior staff capabilities
Process optimization initiatives
Strong negotiation skills with authorities
Collaborative global mindset
Key Requirements
Bachelor's degree in Science; advanced degree preferred
Minimum 10+ years in regulatory project management
Experience with small molecules and biologics globally
Proven track record of successful NDA/BLA/MAA submissions
Leadership experience managing cross-regional teams