SVP, Regulatory Affairs

The role

The Senior Vice President, Regulatory Affairs will lead the global Regulatory Affairs organization. This leader will shape and execute regulatory strategy across the portfolio from preclinical development through approval and lifecycle management.

What you will do

• Lead and evolve Vir Bio's global Regulatory Affairs organization
• Provide strategic counsel to executive leadership
• Define and execute global regulatory strategies across all stages of development
• Lead and oversee regulatory interactions with global Health Authorities
• Lead filing readiness, submission planning, and approval activities
• Assess regulatory risks, opportunities, and emerging trends
• Partner across the organization to integrate regulatory considerations into development plans
• Build, develop, and retain a high-performing Regulatory Affairs organization
• Represent Regulatory Affairs on executive governance and development leadership forums
• Drive operational excellence across the regulatory function

Required qualifications

• 15+ years of Regulatory Affairs experience with a proven track record of leadership and organizational impact across the biotechnology and/or pharmaceutical industry
• Extensive experience developing and executing global regulatory strategies across all stages of development
• Proven track record of leading major regulatory submissions and approvals, including BLA submissions and biologics development
• Significant experience leading regulatory interactions with FDA, EMA, and other global Health Authorities
• Demonstrated ability to influence executive-level decisions and guide complex development programs
• Experience building, developing, and leading high-performing global teams and organizations
• Exceptional communication, relationship-building, and stakeholder management skills

Nice to have

• Advanced scientific or medical degree (PhD, PharmD, MD, or equivalent)

Benefits

• compensation
• bonus
• equity
• health and welfare benefit plans
• non-accrual paid time off
• company shut down for holidays
• commuter benefits
• 401K match
• lunch each day in the office

Before you apply

• Applicants must currently be authorized to work for any employer in the U.S.
• Unable to sponsor or take over sponsorship of an employment Visa at this time
• Vir Biotechnology participates in E-Verify

About the company

Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer.