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Full-Time

Senior Director

CMC Regulatory Affairs

Confirmed live in the last 24 hours

Vir Biotechnology

Vir Biotechnology

501-1,000 employees

Develops treatments for infectious diseases

Healthcare
Biotechnology

Compensation Overview

$250k - $329kAnnually

+ Bonus + Equity + Health Insurance + Dental Insurance + Vision Insurance + Life Insurance + Disability Insurance + Paid Time Off + Commuter Benefits + Child Care Reimbursement + Education Reimbursement + 401K Match

Senior

San Francisco, CA, USA

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

Category
Biology Lab & Research
Biology & Biotech
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.
  • 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 is at the forefront of combating infectious diseases, leveraging advanced technologies such as a proprietary monoclonal antibody platform along with machine learning and artificial intelligence. This focus not only prioritizes public health but also fosters a culture of continuous innovation and commitment to scientific excellence. Working here means contributing to pivotal developments that address some of the most pressing global health challenges today, such as influenza, HIV, and COVID-19, in an environment that values cutting-edge research and a collaborative spirit.

Company Stage

Grant

Total Funding

$908.6M

Headquarters

San Francisco, California

Founded

2016

Growth & Insights
Headcount

6 month growth

1%

1 year growth

3%

2 year growth

9%
Simplify Jobs

Simplify's Take

What believers are saying

  • Recent bullish quarterly reports and increased analyst estimates suggest strong financial performance.
  • Significant investments, such as the $214,000 from Diversified Trust Co, indicate confidence in Vir's future prospects.
  • Presentations at high-profile conferences like J.P. Morgan's Annual Healthcare Conference and AASLD's The Liver Meeting® enhance Vir's visibility and credibility in the biotech community.

What critics are saying

  • Recent layoffs and facility shutdowns indicate potential financial instability and operational challenges.
  • The resignation of key executives, including the CFO and Chief Medical Officer, could lead to strategic and leadership uncertainties.

What makes Vir Biotechnology unique

  • Vir Biotechnology's focus on leveraging immunology expertise to engineer human antibodies into powerful medicines sets it apart from competitors.
  • Their rapid growth, as evidenced by being ranked the fastest-growing company in North America on the 2023 Deloitte Technology Fast 500, highlights their market impact.
  • Vir's ongoing Phase 2 trials for chronic hepatitis delta and B demonstrate their commitment to addressing unmet medical needs with innovative therapies.

Benefits

Comprehensive healthcare coverage

Employer matched 401(k)

Employee stock purchase plan

Childcare assistance

Tuition reimbursement