SVP, Regulatory Affairs

Vir Biotechnology•San Francisco, CA

2d•$350,000 - $400,000•Hybrid

About The Position

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. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple PRO-XTEN® dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies. Vir Biotechnology has exclusive rights to the universal PRO-XTEN® masking platform for oncology and infectious disease. PRO-XTEN® is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company. We believe the success of our colleagues drives the success of our mission. We are committed to creating a company where everyone feels supported and encouraged to give their best. Vir Biotechnology is seeking a strategic and experienced leader to serve as Senior Vice President, Regulatory Affairs. Based in San Francisco and reporting to the Chief Medical Officer, this individual will lead Vir Bio’s global Regulatory Affairs organization. This leader will be responsible for shaping and executing regulatory strategy across the portfolio, spanning preclinical development through approval and lifecycle management. The role will also provide immediate leadership and continuity for Vir Bio’s late-stage HDV program through filing readiness, submission, Health Authority 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 help 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 within a dynamic biotechnology environment. This role is located in our San Francisco headquarters with an expectation of at least 3 days per week in office.

Requirements

A highly experienced, strategic, and collaborative regulatory leader will thrive in this role.
The successful candidate will bring deep expertise across the full product development lifecycle, a proven track record of shaping regulatory strategy for innovative therapies, and experience building and leading high-performing teams.
Equally important, you are an influential leader who can navigate complexity, drive cross-functional alignment, and translate regulatory strategy into successful business and development outcomes.
Advanced scientific or medical degree (PhD, PharmD, MD, or equivalent) preferred
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, from preclinical development 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

Responsibilities

Lead and evolve Vir Bio's global Regulatory Affairs organization, setting the vision, strategy, structure, and capabilities needed to support the company's current and future portfolio
Serve as the company's most senior regulatory leader, providing strategic counsel to executive leadership and influencing key portfolio, development, and business decisions
Define and execute global regulatory strategies across all stages of development, balancing the immediate needs of a late-stage registration program as well as the differentiated regulatory pathways required for innovative early-stage programs.
Lead and oversee regulatory interactions with global Health Authorities, building productive relationships, shaping regulatory pathways, and driving successful outcomes across key markets
Lead filing readiness, cross-functional submission planning and execution, Health Authority review, approval activities, and post-marketing commitments for major regulatory applications, ensuring continuity, clear accountability, and alignment with corporate objectives and development priorities
Assess regulatory risks, opportunities, and emerging trends to inform development strategy, portfolio decisions, and long-term business planning
Partner across the organization to ensure regulatory considerations are integrated into development plans, portfolio strategy, and corporate objectives
Build, develop, and retain a high-performing Regulatory Affairs organization while fostering a culture of collaboration, accountability, innovation, and continuous development
Represent Regulatory Affairs on executive governance, portfolio review, and development leadership forums, serving as a trusted advisor and strategic thought partner to senior leadership
Drive operational excellence across the regulatory function, ensuring effective planning, prioritization, resource allocation, and execution in support of company objectives
Champion Vir Bio’s external presence within the regulatory and biotechnology communities through engagement with Health Authorities, industry organizations, professional societies, and key external stakeholders