Vice President, Regulatory Affairs

Vir Biotechnology, Inc. is an immunology company focused on combining cutting-edge technologies to treat and prevent infectious diseases and other serious conditions. Vir has assembled two technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current clinical development pipeline consists of product candidates targeting hepatitis B and hepatitis delta viruses and human immunodeficiency virus. Vir has several preclinical candidates in its pipeline, including those targeting influenza A and B, COVID-19, RSV/MPV and HPV.

We believe the success of our colleagues drives the success of our mission. We are committed to creating a company passionate about equality, inclusion, and respect. When everyone feels supported and encouraged to give their best, we will collectively deliver outstanding results. We are proud to be the first company to be ranked at the top of the Deloitte Fast 500 list two years in a row (2023 & 2022)!

JOB SUMMARY:

Reporting to the SVP of Regulatory, the VP of Regulatory Affairs will ensure that all programs in the VIR portfolio have a successful non-clinical, clinical and commercial regulatory strategies and submission execution plans. You will lead a team of professionals providing regulatory oversight to each of Vir’s development programs with global and regional expectations. The VP should bring both a track record of successful regulatory approvals that demonstrate core capability in global product development and commercialization, and a passion to challenge conventional paradigms and influence global Health Authorities. The ability to identify challenges and drive solutions is a key to success in this role.

Experience with Health Authority meetings and participation in the global regulatory community through active participation in conferences and workshops (i.e, presentations, organizing activities) is desired. The VP of Regulatory Affairs and the team will work with the Head of Regulatory and leaders of CMC Regulatory, Medical Writing and Regulatory Operations as well as colleagues in Clinical Quality to develop strategic departmental and program objectives.

 RESPONSIBILITIES:

• Provide regulatory leadership and oversight for VIR’s development portfolio
• Ensure program regulatory objectives are aligned with overarching goals of Vir and product development
• Provide regular communications and updates to Vir Sr. Management and liaise with external partners and collaborators
• Lead a team of Regulatory professionals to ensure delivery of expected regulatory goals
• Approve strategy for and ensure leadership of program-specific HA interactions
• Working with colleagues in Policy and Public, Private Partnerships, participate in strategic discussions with multiple governmental and non-governmental agencies
• Ensure overall compliance with regulatory requirements (Safety reporting, Annual Reports, Investigator Updates)
• Ensure development of and compliance with internal SOPs and policies regarding regulatory operations, document management and communication
• Ensure professional development of staff and the overall competency and capability of the team

 

QUALIFICATIONS AND EXPERIENCE:

• BS/MS and 15+ years’ experience in pharmaceutical product development including previous experience overseeing global regulatory activities across a portfolio of programs Senior level accountability for successful filings, including IND/CTA and NDA/BLAs/MAAs
• Strong relationship management skills with development partners
• Track record of successful Health Authority interactions
• Ability to provide regulatory guidance across the company
• Deep understanding of major FDA, EMA, ICH guidelines
• Global filing experience (US, EU, CA, APAC). Working knowledge of Japan, China, LATAM procedures a plus
• Experience with immunologic based therapies is a plus
• A strong track record of collaboration
• Ability to effectively present to Sr. Management
• Experience managing people, with a commitment to developing leaders

 

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The expected salary range for this position is $290,000.00 to $390,000.00. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.

Vir’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 benefits and perks such as: health, dental, vision, life and disability insurance benefits, non-accrual paid time off, company shut down for h