Global Regulatory PM Lead: Strategy & Submissions

BeOne Medicines; United States; On-site; USD 147,000 - 197,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401(k)

FSA/HSA

Life Insurance

Paid Time Off

Wellness

Job summary

BeOne Medicines seeks an Associate Director, Global Regulatory Project Management to lead regulatory strategies across the global lifecycle. You will drive NDA/BLA/MAA submissions and integrate cross-functional activities in US, EU, China, and other regions.

You will guide senior stakeholders, manage complex submissions, and foster a global mindset while mentoring junior staff and ensuring timelines are met across time zones.

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.
• Proven track record of successful submissions across multiple regions.
• Experience leading cross-functional and cross-regional teams, influencing senior stakeholders globally.

Responsibilities

• Translate, implement, and advise on global regulatory strategies across major regions.
• Lead and manage regulatory submissions (IND/CTA, NDA/BLA/MAA) globally.
• Organize cross-functional meetings to coordinate submission activities and track timelines.
• Identify risks and manage issues related to regulatory submissions and strategy.
• Mentor junior staff in regulatory processes and project planning.

Skills

Regulatory project management

Cross-functional leadership

Strategic regulatory thinking

Regulatory submissions

PMP certification

Communication

Global regulatory knowledge

Education

Bachelor's degree in Science

Advanced degree preferred

Tools

Smartsheets

MS Project

Power BI

Microsoft Office

Job description

BeOne Medicines seeks an Associate Director, Global Regulatory Project Management to lead regulatory strategies across the global lifecycle. You will drive NDA/BLA/MAA submissions and integrate cross-functional activities in US, EU, China, and other regions.

You will guide senior stakeholders, manage complex submissions, and foster a global mindset while mentoring junior staff and ensuring timelines are met across time zones.