Remote Global Regulatory Program & Submission Director
BeOne Medicines Ltd.
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Job summary
BeOne Medicines Ltd. seeks a Director, Global Regulatory Project Management to lead global regulatory strategies and submissions across US, EU, China and beyond. You will align cross-functional teams, manage NDA/BLA/MAA timelines, and drive process improvements in a fast-paced oncology development environment.
The role requires 10+ years in regulatory PM, strong leadership, and strategic vision. Remote in the US with competitive compensation and comprehensive benefits.
Qualifications
- Bachelor’s degree in Science or related field; advanced degree preferred.
- 10+ years in regulatory project management and submissions with global exposure.
- Proven strategic regulatory leadership and submissions in multiple regions.
- Experience leading cross-functional and cross-regional teams.
- Strong business acumen and data-driven decision making.
- PMP or similar certification preferred.
Responsibilities
- Lead global regulatory submissions (IND/CTA, NDA/BLA/MAA) across regions.
- Coordinate cross-functional teams and manage timelines.
- Mentor junior staff and drive process improvements.
- Engage with regulatory authorities and senior stakeholders.
- Drive continuous improvement in regulatory PM practices.
Skills
Education
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Job description
BeOne Medicines Ltd. seeks a Director, Global Regulatory Project Management to lead global regulatory strategies and submissions across US, EU, China and beyond. You will align cross-functional teams, manage NDA/BLA/MAA timelines, and drive process improvements in a fast-paced oncology development environment.
The role requires 10+ years in regulatory PM, strong leadership, and strategic vision. Remote in the US with competitive compensation and comprehensive benefits.
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