SVP, Global Regulatory Affairs – Strategic Leader

Vir Biotechnology, Inc.; San Francisco (CA); On-site; USD 350,000 - 400,000; Full time

Benefits offered by this job

Health and welfare benefits

401K match

Lunch provided daily

Commuter benefits

Non-accrual paid time off

Job summary

Vir Biotechnology, Inc. is seeking a strategic Senior Vice President, Regulatory Affairs to lead the global Regulatory Affairs organization from its San Francisco headquarters.

This role partners with leadership to shape regulatory strategy across preclinical through lifecycle management and oversees late-stage HDV program readiness and approvals. The ideal leader has 15+ years in Regulatory Affairs, experience with BLA submissions, and a track record of building high-performing teams in

Qualifications

• 15+ years of Regulatory Affairs experience with leadership impact across biotech/pharma.
• Experience developing and executing global regulatory strategies across all development stages.
• Direct experience with BLA submissions and biologics development.
• Proven ability to influence executive decisions and lead cross-functional teams.

Responsibilities

• Lead Vir Bio's global Regulatory Affairs organization, setting vision, strategy and capabilities.
• Provide strategic counsel to executive leadership and influence portfolio decisions.
• Define and execute global regulatory strategies across all stages of development.
• Oversee regulatory interactions with FDA, EMA, and other Health Authorities.
• Lead filing readiness, submission planning, Health Authority reviews, approvals, and post-marketing commitments.
• Assess regulatory risks and opportunities to inform development strategy and portfolio planning.
• Partner across the organization to integrate regulatory considerations into plans.
• Build, develop and retain a high-performing Regulatory Affairs team.
• Represent Regulatory Affairs in executive governance and development forums.
• Drive operational excellence with planning, prioritization and resource management.
• Champion Vir Bio’s external presence with regulatory bodies and industry groups.

Skills

Regulatory leadership

Global regulatory strategy

FDA/EMA interactions

BLA submissions

Biologics development

Team leadership

Education

Advanced scientific or medical degree

Job description

Vir Biotechnology, Inc. is seeking a strategic Senior Vice President, Regulatory Affairs to lead the global Regulatory Affairs organization from its San Francisco headquarters.

This role partners with leadership to shape regulatory strategy across preclinical through lifecycle management and oversees late-stage HDV program readiness and approvals. The ideal leader has 15+ years in Regulatory Affairs, experience with BLA submissions, and a track record of building high-performing teams in