Vir Biotechnology is a commercial-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus. For more information, please visit www.vir.bio .
We believe the success of our colleagues drives the success of our Mission. We have an ongoing commitment to creating a company passionate about equality, inclusion, and respect. When everyone feels supported and encouraged to give at their best, we will collectively deliver outstanding results.
Reporting to the Head of Regulatory, the VP of Regulatory Affairs (Respiratory) will be accountable for ensuring that all Respiratory programs in the VIR portfolio have a successful non-clinical, clinical and commercial regulatory strategies and submission execution plans. This individual will lead a team of professionals providing regulatory oversight to each of Vir's Respiratory development programs with global and regional expectations. The VP should bring both a track record of successful regulatory approvals that demonstrate core capability in product development and commercialization, as well as a passion to challenge conventional paradigms and influence global Health Authorities. Experience with infectious disease products is a plus. A sense of urgency to identify challenges and problems and a demonstrated ability to take the initiative to identify solutions is a key to success in Vir's dynamic environment.
Significant experience with Health Authority meetings and participation in the global regulatory community through active participation in conferences and/or workshops (i.e, presentations, organizing activities) is highly desired. The VP of Regulatory Affairs and the team will work closely with the Head of Regulatory and leaders of CMC Regulatory and Regulatory Operations as well as colleagues in Clinical Quality to develop strategic departmental and program objectives.
- Provide regulatory leadership and oversight for VIR's Respiratory product 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 as well as liaise with external partners and collaborators
- Lead a team of Regulatory professionals to ensure delivery of expected regulatory goals
- Approve strategy for and ensure adequate leadership of program-specific HA interactions
- Working with colleagues in Policy and Public, Private Partnerships, participate in strategic discussions with various governmental and non-governmental agencies as needed
- 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 in terms of overall competency and capability
QUALIFICATIONS AND EXPERIENCE:
- 15+ years' experience in pharmaceutical product development including previous experience overseeing regulatory activities across a portfolio of programs
- Senior level accountability for successful filings, including IND/CTA and/or NDA/BLAs/MAAs
- Strong relationship management skills with development partners
- Proven track record of successful Health Authority interactions
- Ability to provide strong regulatory leadership on a cross-functional team
- Thorough understanding of major FDA, EMA, ICH guidelines
- Global filing experience (US, EU, CA, APAC). Working knowledge of Japan, China, LATAM procedures a plus.
- Excellent written and verbal communication with strong track record of collaboration
- Ability to effectively present to and influence Sr. Management
- Experience managing people, with a strong commitment to developing leaders
- BS/MS; advanced degree (MD., Ph.D., PharmD, etc) a plus
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, one Friday a month paid-time off, company shut down for holidays, commuter benefits, child care reimbursement, education reimbursement, 401K match and lunch for all lab essential personnel!
Vir is an equal opportunity employer. We value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment. Please contact Human Resources to request accommodation.
Vir Human Resources leads recruitment and employment for Vir. Unsolicited resumes sent to Vir from recruiters do not constitute any type of relationship between the recruiter and Vir and do not obligate Vir 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.