Vir Biotechnology (Vir), a San Francisco based company focused on infectious disease, seeks an exceptional Senior Director of Clinical Regulatory Affairs. Managing a small team of Regulatory Program Leaders, you will be accountable for ensuring all products in the Vir portfolio have a successful regulatory strategy and plan for successful submission execution. Consistent with Vir’s goals to develop novel approaches to prevention and treatment of infectious diseases, we seek to bring innovative, science-based clinical development and regulatory paradigms forward. You should bring both a track record of successful regulatory submissions that demonstrates core capability in infectious disease product development, as well as a passion to challenge conventional paradigms and influence global Health Authorities. Significant experience with Health Authority meetings and participation in the global regulatory community through active participation in conferences and/or workshops is highly desired. You will work closely with the leader of CMC Regulatory to develop program objectives.
Provide regulatory input that supports VIR’s overall product development strategy.
Oversee a small team of Regulatory Program Leaders 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 (Safety reporting, Annual Reports, Investigator Updates). Ensure compliance with internal SOP’s and policies regarding regulatory operations, document management and communication.
QUALIFICATIONS AND EXPERIENCE:
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.
Significant exposure regulatory pathways in infectious disease therapeutic area.
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.
Ph.D. or other relevant advanced degree or certificate.