Senior Director, Regulatory Affairs

Job overview

Senior Director, Regulatory Affairs is an onsite role in San Mateo, CA. Compensation is not specified. The role provides senior regulatory leadership for BeOne Medicines’ U.S. development portfolio and marketed products. The director shapes U.S. regulatory strategy and FDA engagement to support product development, approvals, post-approval commitments, and lifecycle management. The role advises senior leaders, directs regulatory risk management, and coordinates cross-functional teams to advance regulatory objectives and maintain compliance.

What you'll do

• Develop and execute U.S. regulatory strategies
• lead FDA interactions
• oversee preparation and submission of INDs, NDAs, BLAs, supplements, amendments, and related materials
• incorporate regulatory requirements into development and lifecycle plans
• assess and mitigate regulatory risks
• advise cross-functional teams and senior management
• lead regulatory talent development and organizational initiatives.

What we're looking for

Skills & competencies

senior director

regulatory affairs

san mateo ca

beone medicines

u.s. regulatory strategy

fda engagement

regulatory submissions

ind

nda

bla

regulatory risk

pharmaceutical biotechnology

Work arrangement

• Weekend coverage required

Why this role

Primary regulatory leadership for U.S. FDA engagement across development and marketed products.

About the employer

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