SVP, Regulatory Affairs

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 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.

THE OPPORTUNITY

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.

What You’ll Do

• 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

Who You Are And What You Bring

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

Who We Are And What We Offer

The expected salary range for this position is $350,000 to $400,000 per year. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.

Vir Biotechnology's compensation and benefits are aligned with the current market and commensurate with the person’s experience and qualifications. All full-time employees receive a package that includes compensation, bonus and equity as well as many other Vir Biotechnology benefits and perks such as health and welfare benefit plans, non-accrual paid time off, company shut down for holidays, commuter benefits, 401K match and lunch each day in the office.

Applicants must currently be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

All employment decisions at Vir Biotechnology are based on legitimate, non-discriminatory business requirements, job duties and individual qualifications. Employment decisions are made without regard to any legally protected characteristics.

This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs. Vir Biotechnology also strongly commits to providing employees with a work environment free of unlawful conduct or harassment.

Vir Biotechnology Human Resources leads recruitment and employment for Vir Biotechnology. Unsolicited resumes sent to the company from recruiters do not constitute any type of relationship between the recruiter and Vir Biotechnology and do not obligate us to pay fees should we hire from those resumes. We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring manager or employees.

For hires based in the United States, Vir Biotechnology, participates in E-Verify.

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