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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 Regulatory 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 AND LEARNING OPPORTUNITIES:
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 is a clinical-stage immunology company with a compelling mission; “A World Without Infectious Disease”. We are focused on combining immunologic insights with innovative technologies. We have assembled four technology platforms that are designed to stimulate and improve the immune system by exploiting critical observations of natural immune processes. Our current development pipeline consists of product individuals targeting hepatitis B virus, influenza A, SARS-CoV-2, human immunodeficiency virus and tuberculosis.
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.