Full-Time

Senior Director

CMC Regulatory Affairs

Confirmed live in the last 24 hours

Vir Biotechnology

Vir Biotechnology

501-1,000 employees

Develops monoclonal antibodies for infectious diseases

AI & Machine Learning
Biotechnology
Healthcare

Compensation Overview

$250k - $329kAnnually

Senior

No H1B Sponsorship

San Francisco, CA, USA

Requires onsite presence in San Francisco for four days per week.

Category
Legal
Risk & Compliance
Legal & Compliance
Requirements
  • 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.
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.
  • 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.

Vir Biotechnology develops treatments for infectious diseases by harnessing the immune system, using a proprietary platform for monoclonal antibodies (mAbs) combined with machine learning and artificial intelligence. Their pipeline includes candidates for hepatitis B, hepatitis delta, and HIV, as well as investigational antibodies for influenza, COVID-19, and human papillomavirus. What distinguishes Vir from competitors is its collaboration with industry leaders and organizations to expedite scientific advancements. The company's goal is to transform lives by addressing unmet medical needs.

Company Stage

IPO

Total Funding

$640.6M

Headquarters

San Francisco, California

Founded

2016

Growth & Insights
Headcount

6 month growth

2%

1 year growth

-2%

2 year growth

7%
Simplify Jobs

Simplify's Take

What believers are saying

  • Focus on hepatitis drug development could capture significant market share.
  • Licensing agreement with Amunix may expand Vir's therapeutic capabilities.
  • Analysts' boosted estimates suggest positive financial performance and growth potential.

What critics are saying

  • Leadership instability due to resignation of key executives may disrupt operations.
  • Job cuts and facility closures indicate potential financial strain.
  • Struggles to build on COVID-19 success suggest challenges in diversifying portfolio.

What makes Vir Biotechnology unique

  • Vir Biotechnology uses immune programming to manipulate pathogen-host interactions.
  • The company combines monoclonal antibody platform with AI-enhanced capabilities.
  • Vir's pipeline targets hepatitis B, hepatitis delta, HIV, and influenza.

Help us improve and share your feedback! Did you find this helpful?

Benefits

Comprehensive healthcare coverage

Employer matched 401(k)

Employee stock purchase plan

Childcare assistance

Tuition reimbursement