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SENIOR DIRECTOR, CMC REGULATORY

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.

Vir Biotechnology (Vir), a San Francisco based immunology company focused on infectious disease, seeks an exceptional Senior Director of CMC Regulatory Affairs accountable for ensuring all products in the Vir portfolio have a successful regulatory CMC strategy for clinical development and commercialization. Consistent with Vir's goals to develop novel approaches to prevention and treatment of infectious diseases, we seek to bring innovative, science-based regulatory paradigms forward. You should bring both a track record of successful regulatory submissions that demonstrates core capability in technical (CMC) development, as well as a passion to challenge conventional paradigms and influence global Health Authorities. Vir is committed to impacting the significant burden of infectious disease through immune modulatory strategies that might involve a number of types of products. Therefore, we are looking for someone with experience or willingness to expand to cover multiple modalities, including recombinant biologics (including monoclonals, vectored vaccines, gene and cell therapy), oligonucleotides and small molecule products. Significant experience with Health Authority meetings is required, and participation in the global regulatory community through active participation in conferences and/or workshops is highly desired. This position will require regular interaction with senior management from multiple internal functional areas, corporate partners, international regulators and external experts, and has significant possibilities for further development. You will work closely with the Head of Regulatiory and the leader of Clinical Regulatory to develop program objectives. Initially the Head of CMC will oversee a network of consultants to deliver CMC elements of regulatory submissions, and have the opportunity to build an internal team once on-board.

RESPONSIBILITIES

    • Provide regulatory input that supports VIR's overall product development strategy.
    • Oversee a small team of Regulatory professionals to ensure the individual products in the Vir portfolio have successful regulatory strategies.
    • Plan strategy for and lead HA interactions.
    • Participate in strategic discussions with various governmental and non-governmental agencies as needed.
    • Participate in development of regulatory intelligence in areas of key importance to Vir and influence international regulatory policies and guidance through active participation in commenting processes and conferences.
    • Ensure overall compliance with regulatory requirements
    • Ensure compliance with internal SOP's and policies regarding regulatory operations, document management and communication.



QUALIFICATIONS AND EXPERIENCE

    • B.S., M.S., Ph.D. or other relevant advanced degree or certificate.
    • 15+ years' experience in pharmaceutical product development including previous experience overseeing a portfolio of regulatory programs.
    • Senior level accountability for successful filings including IND/CTA and/or NDA/BLA's.
    • Proven track record of successful Health Authority interactions.
    • Thorough understanding of major FDA, EMA, ICH guidelines.
    • Global filing experience (US, EU, CA, Aus, NZ). 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 Senior Management.
    • Experience managing people, with a strong commitment to developing leaders.



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.

SENIOR DIRECTOR, CMC REGULATORY

San Francisco, CA
Full Time

Published on 09/10/2021

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