Global Regulatory Project Lead: Submissions & Strategy

Regulatory Jobs; United States; Remote; USD 147,000 - 197,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k)

Employee Stock Purchase Plan

Paid Time Off

Job summary

BeOne Medicines Ltd. is seeking an Associate Director, Global Regulatory Project Management to lead strategic regulatory efforts across the global lifecycle.

You will drive NDA/BLA/MAA submissions, coordinate cross-functional teams, and shape global regulatory strategies from US to EU, China, and beyond. The role requires 8+ years in regulatory project management, strong leadership, and expertise in IND/CTA submissions.

Qualifications

• Bachelor’s degree in Science or related discipline; advanced degree preferred.
• 8+ years of experience in regulatory project management and regulatory submissions with global exposure.
• Experience leading cross-functional and cross-regional teams; influencing senior stakeholders.
• PMP or similar certification preferred.
• Excellent verbal and written communication; able to translate complex regulatory issues.

Responsibilities

• Translate, implement, and advise on global regulatory strategies across major regions.
• Lead and manage complex regulatory submissions (IND/CTA, NDA/BLA/MAA) across regions.
• Organize cross-functional meetings to coordinate submission activities.
• Mentor junior staff and foster a global mindset.
• Champion process optimization within the global regulatory PM function.

Skills

Regulatory strategy

Global regulatory

Project management

Cross-functional leadership

Regulatory affairs

Risk management

Education

Bachelor's degree in Science or related discipline

Advanced degree preferred

Tools

Smartsheets

MS Project

Power BI

Microsoft Office

Job description

BeOne Medicines Ltd. is seeking an Associate Director, Global Regulatory Project Management to lead strategic regulatory efforts across the global lifecycle.

You will drive NDA/BLA/MAA submissions, coordinate cross-functional teams, and shape global regulatory strategies from US to EU, China, and beyond. The role requires 8+ years in regulatory project management, strong leadership, and expertise in IND/CTA submissions.