Global Regulatory Submissions & Programs Leader

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

Job summary

BeOne Medicines Ltd. in the United States is seeking an Associate Director, Global Regulatory Project Management (AD, Global RPM) to lead regulatory strategy and submissions across the global development lifecycle.

You will translate strategy into actionable plans and coordinate cross-functional teams across regions to secure timely approvals. With 8+ years in regulatory PM, you will partner with senior stakeholders, drive process improvements, and mentor junior staff while navigating US, EU,

Qualifications

• Bachelor’s degree in Science or related; advanced degree preferred.
• 8+ years in regulatory project management and submissions with global exposure.
• Proven strategic regulatory leadership with cross-regional submissions.
• Experience leading cross-functional and cross-regional teams; strong business acumen.
• Excellent verbal and written communication; PMP or similar certification preferred.

Responsibilities

• Lead and manage strategic regulatory submissions (IND/CTA, NDA/BLA/MAA) globally.
• Act as COO to Global Regulatory Lead, translating vision into actionable plans.
• Coordinate cross-functional meetings to drive submission plans and timelines.
• Proactively identify risks and resolve issues in global regulatory strategies.
• Mentor junior staff and foster a culture of high performance and collaboration.

Skills

Strategic regulatory leadership

Cross-functional leadership

Global regulatory submissions

Project management

Communication skills

Education

Bachelor's degree in Science or related

Advanced degree preferred

Tools

Smartsheets

MS Project

Power BI

MS Office

Regulatory submission platforms

Job description

BeOne Medicines Ltd. in the United States is seeking an Associate Director, Global Regulatory Project Management (AD, Global RPM) to lead regulatory strategy and submissions across the global development lifecycle.

You will translate strategy into actionable plans and coordinate cross-functional teams across regions to secure timely approvals. With 8+ years in regulatory PM, you will partner with senior stakeholders, drive process improvements, and mentor junior staff while navigating US, EU,