Career | <?phpecho $jobTitle;?> | <?phpecho $companyName;?>

Director CMC Regulatory Affairs

Vir Biotechnology

Remote / United States of America
  • Job Type: Full-Time
  • Function: Regulatory Affairs
  • Industry: Health Tech
  • Post Date: 03/16/2023
  • Website: vir.bio
  • Company Address: 499 Illinois St, San Francisco, CA , 94158
  • Salary Range: $50,000 - $150,000

About Vir Biotechnology

Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases.

Job Description

Vir Biotechnology is a commercial-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B and hepatitis D viruses, influenza A and human immunodeficiency virus.

We believe the success of our colleagues drives the success of our mission. We are committed to creating a company passionate about equality, inclusion, and respect. When everyone feels supported and encouraged to give their best, we will collectively deliver outstanding results. We are proud to have been ranked the fastest-growing company in North America on the 2022 Deloitte Technology Fast 500™.

 

Vir Biotechnology (Vir), a San Francisco based immunology company focused on infectious disease, seeks an enthusiastic Director of Regulatory CMC accountable for ensuring all assigned products have a successful regulatory CMC strategy for clinical development and commercialization. Consistent with Vir's goals to develop novel approaches to prevention and treatment of infectious diseases, we seek to bring creative, science-based regulatory paradigms forward. 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. Vir is committed to impacting the significant burden of infectious disease through immune modulatory strategies that might involve a number of types of products. Therefore, we are looking for someone with experience or willingness to expand to cover multiple modalities, including biologics (including monoclonal, vectored vaccines, gene and cell therapy), oligonucleotides and small molecule products. 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 empowerment, continuous learning and diversity and inclusion. You 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.

RESPONSIBILITIES

  • Develop, communicate and execute sound regulatory strategies that meet global regulatory requirements and enable Vir business objectives.
  • 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.
  • 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.

QUALIFICATIONS AND EXPERIENCE

  • B.S., M.S., Ph.D. or other relevant advanced degree or certificate.
  • 12+ years' experience in pharmaceutical product development including global Regulatory CMC leadership.
  • Regulatory CMC product lead accountability for successful filings including IND/CTA and NDA/BLA's.
  • Experience with CMC regulatory considerations for late stage and/or commercial biologics and experience with other advanced modalities (e.g., Cell/Gene therapy).
  • 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.
  • Ability to effectively present to Senior Management.

#LI-Remote

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 lab essential personnel!

Vir is an equal opportunity employer.  We value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment. Please contact Human Resources to request accommodation.

Vir Human Resources leads recruitment and employment for Vir. Unsolicited resumes sent to Vir from recruiters do not constitute any type of relationship between the recruiter and Vir and do not obligate Vir 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.