Vir Biotechnology

Vir Biotechnology

Director, CMC Regulatory Affairs

San Francisco, California, United States · Director · Full-time

No sponsorship$196k-$273kDetected 26 days ago
HRIntellectual PropertyFDA RegulatoryAnimal StudiesLeadershipRegulatory Affairs

About the role

  • Vir Biotechnology is seeking an a highly motivated, self-driven and enthusiastic Director of Regulatory CMC accountable for ensuring all assigned products have a successful regulatory CMC strategy for clinical development and commercialization.
  • 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.
  • We are looking for someone with experience or willingness to expand to cover multiple modalities.

Responsibilities

  • As a member of the CMC project teams, provide strategic CMC regulatory leadership to develop and execute sound regulatory strategies that meet global regulatory requirements and enable Vir business objectives
  • Plan strategy for and lead HA interactions for CMC specific issues
  • Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer.
  • We believe the success of our colleagues drives the success of our mission.

Requirements

  • B.S., M.S., Ph.D. or other relevant advanced degree or certificate
  • 10+ years experience in pharmaceutical product development including strong global Regulatory CMC leadership
  • Regulatory CMC experience leading both development projects (IND/CTA) and initial registration (BLA/MAA)
  • Ability to effectively present to Senior Management

Nice to have

  • Experience with CMC regulatory considerations for late stage and/or commercial large molecules (biologics) is required experience with combination product or oligonucleotide experience is a plus
  • Preference will be given to candidates with recent experience with initial BLA and/or NDA (CMC sections).
  • Management of US post-market, biologic product CMC changes is a plus
  • Global clinical filing experience (US, EU, UK, CA,).
  • Working knowledge of other global clinical territories procedures a plus

Compensation

  • The expected salary range for this position is $195,500 to $272,500.

Benefits

  • This position will work closely with the Technical Operations (CMC) functional groups and Regulatory Affairs department to plan and lead high quality regulatory submissions to health authorities.
  • Experience with Health Authority interactions is desirable

Company info

  • The expected salary range for this position is $195,500 to $272,500.
  • Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.
  • Vir Biotechnology's compensation and benefits are aligned with the current market and commensurate with the person's experience and qualifications.
  • All full-time employees receive a package that includes compensation, bonus and equity as well as many other Vir Biotechnology benefits and perks such as health and welfare benefit plans, non-accrual paid time off, company shut down for holidays, commuter benefits, 401K match and lunch each day in the office.
  • Applicants must currently be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
  • All employment decisions at Vir Biotechnology are based on legitimate, non-discriminatory business requirements, job duties and individual qualifications.
  • Employment decisions are made without regard to any legally protected characteristics.
  • This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs.
  • Vir Biotechnology also strongly commits to providing employees with a work environment free of unlawful conduct or harassment.
  • Vir Biotechnology Human Resources leads recruitment and employment for Vir Biotechnology.
  • Unsolicited resumes sent to the company from recruiters do not constitute any type of relationship between the recruiter and Vir Biotechnology and do not obligate us to pay fees should we hire from those resumes.
  • We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring manager or employees.
  • For hires based in the United States, Vir Biotechnology, participates in E-Verify.

Equal opportunity

  • The ideal candidate will contribute to a culture of high performance, empowerment, continuous learning and diversity and inclusion.

Visa & Work Authorization

  • Applicants must currently be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
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This listing is sourced directly from Vir Biotechnology's careers page and normalized into a canonical job model.