Global Regulatory Project Lead: Strategy & Submissions

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

Job summary

The BeOne Medicines Ltd. in the United States seeks an Associate Director, Global Regulatory Project Management (AD, Global RPM) to steer regulatory strategy across the global drug development lifecycle, including NDA/BLA submissions and lifecycle management.

This role blends regulatory expertise with advanced project leadership to secure worldwide market access. You will lead cross‑regional submissions, manage cross‑functional teams, and proactively mitigate regulatory risks while driving

Qualifications

• Bachelor's degree in Science or related discipline; advanced degree preferred.
• Minimum 8+ years of experience in regulatory project management with global exposure.
• Demonstrated leadership in regulatory submissions across multiple regions.
• Experience leading cross-functional and cross-regional teams.
• Strong business acumen, strategic thinking, and data-driven decision making.

Responsibilities

• Translate, implement, and oversee global regulatory strategies for development programs.
• Lead complex regulatory submissions (IND/CTA, NDA/BLA/MAA) across regions.
• Coordinate cross-functional meetings to plan and track submission activities.
• Identify risks, propose solutions, and manage critical issues in global submissions.
• Oversee documentation to support investigational and marketing registrations.

Skills

Regulatory strategy

Global leadership

Cross-functional collaboration

Project management

Regulatory submissions

Risk management

Regulatory knowledge

Communication

Education

Bachelor's degree in Science

Advanced degree preferred

Tools

Smartsheets

MS Project

Power BI

MS Office Suite

Job description

The BeOne Medicines Ltd. in the United States seeks an Associate Director, Global Regulatory Project Management (AD, Global RPM) to steer regulatory strategy across the global drug development lifecycle, including NDA/BLA submissions and lifecycle management.

This role blends regulatory expertise with advanced project leadership to secure worldwide market access. You will lead cross‑regional submissions, manage cross‑functional teams, and proactively mitigate regulatory risks while driving