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ASSOCIATE DIRECTOR, CMC REGULATORY AFFAIRS

Vir Biotechnology is a clinical-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. Our current development pipeline consists of five product candidates targeting SARS-CoV-2, hepatitis B virus, influenza A, human immunodeficiency virus and tuberculosis.

Vir Biotechnology (Vir), a San Francisco based immunology company focused on infectious disease, seeks an exceptional Associate Director of CMC Regulatory Affairs. You will be accountable for advising on regulatory CMC strategy and submission management for clinical stage programs. You should bring both a track record of successful regulatory submissions that demonstrates strong knowledge in technical (CMC) requirements, as well as passion for working with CMC teams to develop science and risk-based approaches. Vir is committed to impacting the significant burden of infectious disease through immune modulatory strategies that might involve a number of types of products. Experience with recombinant biologics, particularly with monoclonal antibodies, vectored vaccines, or cell therapy products is required. However, willingness to learn new modalities is also important. Significant experience with Health Authority interactions through written communication, development of high-quality briefing documents and well and management of HA meetings is required. This position will report to the Head of CMC Regulatory.

RESPONSIBILITIES

    • Provide regulatory input that supports VIR's overall product development strategy.
    • Oversee development of major submissions, briefing documents and routine updates
    • Provide CMC Regulatory input to teams' CMC strategy
    • 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

    • 10+ years' experience in bioproduct technical development with a significant track record in CMC regulatory
    • Previous responsibility 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 cross-functional teams.



EDUCATION

    • B.S., M.S., or other relevant advanced degree or certificate.



Vir is a company with a compelling mission, "A World Without Infectious Disease". We believe the success of our colleagues drives the success of our business. This is reflected in our ongoing commitment to creating an environment focused on equality, inclusion, and respect. When everyone feels supported and inspired to contribute at their best, we will collectively deliver amazing results.

Vir is committed to attracting and employing a diverse workforce to strengthen our values and mission. Qualified applicants will receive consideration without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, gender expression, veteran status, or disability.

The Human Resources team manages the recruitment and employment process 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 Recruiters not contact or present candidates directly to our hiring manager or employees.

ASSOCIATE DIRECTOR, CMC REGULATORY AFFAIRS

San Francisco, CA
Full Time

Published on 12/01/2020