SVP, Regulatory Affairs

Vir Biotechnology•San Francisco, CA

1d•Hybrid

About The Position

Vir Biotechnology is seeking a strategic, experienced regulatory executive to lead its global Regulatory Affairs organization. Based in the company’s San Francisco headquarters and reporting to the Chief Medical Officer, the SVP will shape and execute regulatory strategy across the portfolio, from preclinical development through approval and lifecycle management. The role includes providing leadership and continuity for the late-stage chronic hepatitis delta program through filing readiness, submission, Health Authority review, and potential approval. As a member of the Development Leadership Team, the SVP will partner across the organization to advance development programs, inform portfolio decisions, and support the development of medicines for patients worldwide. The leader will advise executive leadership, guide regulatory and business decisions, lead Health Authority engagement, build and develop a high-performing Regulatory Affairs team, and ensure effective planning and execution across the function. The role is based in San Francisco, with an expectation of at least three days per week in the office.

Requirements

15+ years of Regulatory Affairs experience with a record of leadership and organizational impact in 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 leading major regulatory submissions and approvals, including direct experience with BLA submissions, biologics development, and global registration strategies.
Significant experience leading regulatory interactions with the 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.
Applicants must currently be authorized to work for any employer in the U.S.; visa sponsorship or transfer is not available.

Nice To Haves

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

Responsibilities

Lead and evolve the global Regulatory Affairs organization, setting its vision, strategy, structure, and capabilities.
Provide strategic regulatory counsel to executive leadership and influence portfolio, development, and business decisions.
Define and execute global regulatory strategies across development stages, from preclinical development through approval and lifecycle management.
Balance the needs of a late-stage registration program with regulatory pathways for innovative early-stage programs.
Lead and oversee interactions with global Health Authorities, build productive relationships, shape regulatory pathways, and drive successful outcomes.
Lead filing readiness, cross-functional submission planning and execution, Health Authority review, approval activities, and post-marketing commitments for major regulatory applications.
Assess regulatory risks, opportunities, and emerging trends to inform development strategy, portfolio decisions, and long-term business planning.
Integrate regulatory considerations into development plans, portfolio strategy, and corporate objectives.
Build, develop, and retain a high-performing Regulatory Affairs organization and foster collaboration, accountability, innovation, and continuous development.
Represent Regulatory Affairs in executive governance, portfolio review, and development leadership forums.
Drive operational excellence, including effective planning, prioritization, resource allocation, and execution.
Represent Vir Biotechnology within regulatory and biotechnology communities through engagement with Health Authorities, industry organizations, professional societies, and other external stakeholders.