Manager, Regulatory Affairs

Vir Biotechnology

San Francisco, California, United States
Base: $121,500 to $170,500 py; bonus/equity: inclu...
On-site
Coordinate regulatory submissions
Manage internal reviews
Ensure fda and ich compliance
Vir Biotechnology is a clinical-stage biopharmaceutical company focused on discovering medicines for serious infectious diseases and cancer

Job Summary

  • Vir Biotechnology is a clinical-stage biopharmaceutical company focused on discovering medicines for serious infectious diseases and cancer.
  • The successful candidate will coordinate documents for regulatory submissions ensuring alignment with local and regional registration requirements.
  • Employees receive a comprehensive package including compensation, bonus, equity, health benefits, and daily lunch in the office.

Matching Summary

Vir Biotechnology is a clinical-stage biopharmaceutical company focused on discovering medicines for serious infectious diseases and cancer.

Salary

Base: $121,500 to $170,500 per year; Bonus/Equity: Included in compensation package; Benefits: Health/welfare plans, PTO, 401K match, daily lunch

Skills & Requirements

Must-have

  • Coordinate regulatory submissions
  • Manage internal reviews
  • Ensure FDA and ICH compliance
  • Track INDs and CTAs
  • Knowledge of eCTD

Nice-to-have

  • Experience with ex-US regulations
  • Excellent verbal communication skills
  • Ability to work on multiple projects
  • Participate in process development
  • Strong interpersonal skills

Key Requirements

  • BS degree with 8+ years experience or MS with 6+ years
  • Minimum 5+ years of regulatory experience
  • Working knowledge of US FDA regulations
  • Must be authorized to work in the U.S.
  • No visa sponsorship available

Work Rights

Must be authorized to work for any employer in the U.S.

Tailored Resume

Cover Letter