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Salary: USD 350,000 - 400,000 / annual
Vir Biotechnology, a clinical-stage biopharmaceutical company, is seeking a Senior Vice President of Regulatory Affairs to lead its global regulatory organization. Based in San Francisco and reporting to the Chief Medical Officer, this executive will shape and execute regulatory strategy across the company's portfolio spanning preclinical development through approval and lifecycle management. The role carries immediate responsibility for advancing Vir Bio's late-stage hepatitis delta (HDV) program through filing readiness, Health Authority submission, review, and potential approval.
As a key member of the Development Leadership Team, the SVP will partner across the organization to advance development programs, inform portfolio decisions, and bring innovative medicines to patients worldwide. The ideal candidate is an accomplished regulatory executive with deep experience leading global regulatory strategy across the full product development lifecycle, including significant Health Authority interactions, BLA submissions, biologics development, and major regulatory approvals. This leader has a proven track record of building high-performing teams, influencing key business and development decisions, and successfully navigating complex regulatory challenges.
Key responsibilities include: leading and evolving Vir Bio's global Regulatory Affairs organization with vision, strategy, structure, and capabilities; serving as the company's most senior regulatory leader providing strategic counsel to executive leadership; defining and executing global regulatory strategies across all development stages; leading regulatory interactions with global Health Authorities and building productive relationships; overseeing filing readiness, cross-functional submission planning and execution, Health Authority review, and approval activities; assessing regulatory risks and opportunities to inform development strategy and portfolio decisions; ensuring regulatory considerations are integrated into development plans and corporate objectives; building and retaining a high-performing Regulatory Affairs team; representing Regulatory Affairs on executive governance and portfolio review forums; driving operational excellence across the regulatory function; and championing Vir Bio's external presence within regulatory and biotechnology communities.
The role is located in San Francisco headquarters with an expectation of at least 3 days per week in office.
REQUIREMENTS:
- Advanced scientific or medical degree (PhD, PharmD, MD, or equivalent) preferred
- 15+ years of Regulatory Affairs experience with proven track record of leadership and organizational impact in biotechnology and/or pharmaceutical industry
- Extensive experience developing and executing global regulatory strategies across all stages of development, from preclinical through approval and lifecycle management
- Proven track record of leading major regulatory submissions and approvals, including direct experience with BLA submissions, biologics development, and global registration strategies
- Significant experience leading regulatory interactions with FDA, EMA, and other global Health Authorities
- Demonstrated ability to influence executive-level decisions, balance risk, and guide complex development programs
- Experience building, developing, and leading high-performing global teams and organizations
- Exceptional communication, relationship-building, and stakeholder management skills
- Must be currently authorized to work for any employer in the U.S.
