Senior Director, Clinical Regulatory Affairs

Location
94158, San Francisco
Posted
Jun 29, 2018
Required Education
Doctorate/PHD/MD
Position Type
Full time

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.

RESPONSIBILITIES:

  • 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.

EDUCATION:

  •  Ph.D. or other relevant advanced degree or certificate.