Vir Biotechnology 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 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.
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 looking for a Regulatory Writing Senior Director who will support all aspects of regulatory submissions writing needs. You will collaborate with senior management and other leads to support consistent documents/messaging within and across programs.
This Person will report to the SVP, Regulatory.
WHAT YOU'LL DO- Lead the development of clear, accurate, and compliant regulatory documents for global health authorities (FDA, EMA, PMDA), serving as the author for complex submissions
- Author and oversee critical regulatory documents including: Clinical trial protocols and amendments, Investigator Brochures (IBs), Clinical Study Reports (CSRs), briefing packages, regulatory submission dossiers (e.g., NDA, IND, MAA) and summary documents, such as summaries of safety and efficacy.
- Serve as the regulatory writing lead for high-priority programs, managing end-to-end document development from strategy through submission, including coordination of cross-functional input and review cycles
- Analyze complex scientific and medical information, including clinical trial data, and translating it into clear, concise, and accurate language understandable by both technical and non-technical audiences.
- Work closely with cross-functional teams (e.g., clinical, biostatistics, regulatory affairs, pharmacology, safety) to gather data and ensure comprehensive and accurate documentation.
- Drive continuous improvement in regulatory writing processes, templates, and standards, implementing best practices and innovative approaches to enhance efficiency and quality
- Analyze and synthesize complex scientific, clinical, and nonclinical data from multiple sources to create compelling, scientifically rigorous regulatory narratives that address anticipated health authority questions
- Bachelor's Degree in Life Sciences with 18+ years, Master's with 15+ years, or PhD with 13+ years of hands-on regulatory writing experience in biotechnology/pharmaceutical industry
- Experience with most of the more common regulatory documents such as CSRs, IBs, DSURs, protocols, and clinical modules.
- Deep knowledge of eCTD structure, ICH guidelines (particularly E3, M4), global regulatory requirements, and GxPs, with ability to navigate ambiguous or evolving regulatory landscapes
- Involvement with marketing applications (INDs, BLAs, NDAs, MAAs, or equivalents), preferably including responses to questions, 120-day safety updates, or other post-submission activities.
- Proven ability to work independently on complex projects while effectively collaborating with and influencing cross-functional stakeholder
- Minimum 10 years as a lead/senior regulatory writer with increasing scope and complexity of assignments
WHO WE ARE AND WHAT WE OFFER
The expected salary range for this position is $227,000 to $318,000. 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.
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