Director, Global Regulatory Submissions

BeiGene; United States; Remote; USD 176,000 - 236,000; Full time

Job summary

BeOne Medicines Ltd. is seeking a Director of Global Regulatory Project Management to lead global regulatory strategies and submissions across development programs.

This senior role reports to the GRL and partners with regional leads to drive on-time NDA/BLA/MAA submissions and lifecycle management. The successful candidate will oversee cross-functional teams, optimize regulatory processes, and mentor staff while traveling as needed to support global project teams.

Qualifications

• Bachelor’s degree in Science or related discipline; advanced degree preferred.
• 10+ years of experience in regulatory project management and submissions with global exposure.
• Proven strategic regulatory leadership with successful submissions in multiple regions.
• Experience leading cross-functional and cross-regional teams.
• Strong business acumen, strategic thinking, and data integration for decisions.
• Excellent verbal and written communication; translate complex regulatory issues clearly.
• PMP or similar certification preferred.

Responsibilities

• Lead and manage complex regulatory submissions (IND/CTA, NDA/BLA/MAA) across regions.
• Translate strategic regulatory vision into actionable project plans.
• Organize cross-functional meetings to coordinate submission activities.
• Identify risks and manage issues related to submissions and strategy.
• Oversee preparation and submission of documentation for investigational and marketing packages.

Skills

Strategic leadership

Global regulatory knowledge

Project management

Cross-functional leadership

Regulatory submissions

Stakeholder management

Education

Bachelor's degree in Science or related discipline

Advanced degree preferred

Tools

Smartsheets

MS Project

Power BI

Regulatory submission platforms

Job description

BeOne Medicines Ltd. is seeking a Director of Global Regulatory Project Management to lead global regulatory strategies and submissions across development programs.

This senior role reports to the GRL and partners with regional leads to drive on-time NDA/BLA/MAA submissions and lifecycle management. The successful candidate will oversee cross-functional teams, optimize regulatory processes, and mentor staff while traveling as needed to support global project teams.