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San Francisco, California, United States · Hybrid
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San Francisco, California, United States · Hybrid
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San Francisco, California, United States • Hybrid
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Lead the development and execution of global CMC regulatory strategies for clinical development and commercialization of biopharmaceutical products. Manage regulatory submissions, health authority interactions, and lifecycle changes for INDs, CTAs, BLAs, and MAAs.
Requires a degree in a relevant field and over 10 years of experience in pharmaceutical product development with a focus on global Regulatory CMC leadership. Must have experience with biologics and initial registration filings such as BLAs or NDAs.
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. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple PRO-XTEN® dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies.
Vir Biotechnology has exclusive rights to the universal PRO-XTEN® masking platform for oncology and infectious disease. PRO-XTEN® is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company.
We believe the success of our colleagues drives the success of our mission. We are committed to creating a company where everyone feels supported and encouraged to give their best.
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. 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 lead high quality regulatory submissions to health authorities.
This role is located in our San Francisco headquarters with an expectation of 3 days per week in office.
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.
Powering the Immune System to Transform Lives
At Vir Biotechnology, Inc., we leverage the immense potential of the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. We focus on the therapeutic areas in which we believe we can most benefit patients. Our foundational efforts in chronic hepatitis delta are complemented by strategic programs in oncology. Every day, we work with the utmost urgency to deliver potentially transformative medicines for patients. Our pipeline is built on two technology platforms which enable us to rapidly identify, optimize and advance candidates from concepts to the clinic: our next-generation antibody platform and our protease-releasable masking platform in infectious disease and cancer. Explore our full pipeline here: https://bit.ly/3tr7FPm It has come to our attention that there have been various recruitment scams targeting job seekers on LinkedIn. Vir Biotechnology, Inc. is committed to your privacy and will never request sensitive personal information including banking details through email, text message, social media or video software platforms. We also will never request a financial commitment from a candidate as part of the application process. Learn more about Vir Bio's recruiting process: https://bit.ly/461EgJN
Offices: 1800 Owens St, Suite 900, San Francisco, California 94158, US · Via Mirasole 1, Bellinzona, Ticino 6500, CH
Based on 188 listings with disclosed salaries, most legal jobs in San Francisco, CA pay between $83k–$250k per year. Individual offers vary with seniority, company size, and specialization.
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