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A World Without Infectious Disease
Senior Director, Regulatory Writing
Location
United States
Posted
128 days ago
Salary
$227K - $318K / year
Seniority
Senior
Job Description
Senior Director, Regulatory Writing
Vir Biotechnology, Inc.
• 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
Job Requirements
- 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
Benefits
- health and welfare benefit plans
- non-accrual paid time off
- company shut down for holidays
- commuter benefits
- 401K match
- lunch each day in the office
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