Teams at Vir Biotechnology

Lead and produce high-quality regulatory submission documents (protocols, IBs, CSRs, Module 2/5 summaries, labeling, briefing packages) for FDA/EMA. Ensure compliance with ICH/GxP, manage writing projects and timelines, collaborate with cross-functional teams, and define SOPs and best practices.

Lead nonclinical toxicology strategy across infectious disease and oncology programs. Oversee GLP/non-GLP safety studies, design and interpret toxicology reports, support regulatory submissions (IND/BLA/CTAs/IMPDs), advise cross-functional teams, and drive safety risk assessment and lifecycle management.

Create, edit, and ensure compliance of regulatory submission documents (protocols, IBs, CSRs, Module 2/5 summaries) for global health authorities. Translate complex clinical data into clear text, coordinate cross-functional inputs, manage writing timelines, and advise teams on regulatory writing best practices to support IND/NDA/MAA and other submission activities.