Senior Director, CMC Regulatory Affairs

Company: Vir Biotechnology, Inc.
Location: San Francisco
Posted on: November 16, 2024

Job Description:

The opportunity
Vir Biotechnology is seeking a highly motivated, self-driven and enthusiastic Senior 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. Experience with Health Authority meetings and participation in the global regulatory community through active participation in conferences and/or workshops is desired. The ideal candidate will contribute to a culture of high performance, empowerment, continuous learning and diversity and inclusion. This position will work closely with the Technical Operations (CMC) functional groups and Regulatory Affairs department to plan and author high quality regulatory submissions to health authorities and will have frequent interaction with internal senior management, corporate partners, international regulators and external experts.
This role is located in San Francisco at our corporate office.
What you'll do

• 
  
• 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.
  
• Provide CMC regulatory expertise to enable global development and registration for INDs, CTAs, BLAs and MAAs.
  
• Identify and communicate regulatory risks and facilitate the development and execution of risk mitigation strategies in concert with Technical Operation functions.
  
• Plan strategy for and lead HA interactions for CMC specific issues.
  
• Manage CMC regulatory changes throughout the product life cycle, including support for relevant quality systems related to change control, discrepancy management, as well as Health Authority inspection support as required.
  
• Ensure overall compliance with regulatory requirements.
  
• Ensure compliance with internal SOP's and policies regarding regulatory operations, document management.
  
• Contribute to regulatory excellence by identifying opportunities and supporting continuous improvement.
  
  Who you are and what you bring
  
  • 
    
  • B.S., M.S., Ph.D. or other relevant advanced degree or certificate.
    
  • 12+ 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).
    
  • Experience with CMC regulatory considerations for late stage and/or commercial large molecules (biologics) is required; experience with combination products is a plus.
    
  • Proven track record of successful Health Authority interactions is preferred.
    
  • 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.
    
    Who we are and what we offer:
    The expected salary range for this position is $250,000 to $329,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.
    Vir'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 benefits and perks such as: health, dental, vision, life and disability insurance benefits, non-accrual paid time off, company shut down for holidays, commuter benefits, child care reimbursement, education reimbursement, 401K match and lunch for all onsite employees!
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Keywords: Vir Biotechnology, Inc., Hayward , Senior Director, CMC Regulatory Affairs, Executive , San Francisco, California