Director, Global Regulatory Project and Submission Management

Job overview

The Director, Global Regulatory Project and Submission Management role is onsite in Emeryville, California. Compensation is not specified. The role supports global oncology regulatory strategies and submission execution across the drug development lifecycle at BeOne Medicines.

What you'll do

• Support, translate, and implement global regulatory strategies
• advise Global and Regional Regulatory Leads
• lead complex IND/CTA, NDA/BLA, and MAA submissions across regions
• translate regulatory strategy into project plans and coordinate cross-functional activities
• facilitate global meetings, track submission work, identify risks, and manage critical issues
• oversee preparation and submission of registration documentation
• collaborate with clinical, medical, safety, CMC, and commercial teams and regulatory authorities
• mentor staff
• lead process optimization and regulatory process development.

What we're looking for

Skills & competencies

director

global regulatory project management

regulatory submissions

beone medicines

emeryville ca

oncology

ind/cta

nda/bla/maa

global drug development

cross-regional collaboration

regulatory strategy

Work arrangement

• Weekend coverage required

Why this role

Combines global regulatory expertise with project management and organizational leadership across small-molecule and biologic submissions.

About the employer

BeOne Medicines is hiring for this role. Industry: Pharmaceutical Preparation Manufacturing. Sector: 32.