Regulatory Writer – Regulatory QC/Editor

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Vir Biotechnology, Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2016

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

Vir Biotechnology, Inc. is a company focused on leveraging the potential of the immune system to address critical unmet medical needs and improve patient outcomes. It specializes in the discovery, engineering, and development of antibody-based medicines for viral health challenges such as COVID-19 and Ebola. Vir Biotechnology employs innovative platforms like the next-generation antibody and the PRO-XTEN™ protease-releasable masking technologies. With a therapeutic concentration on infectious diseases like hepatitis B and delta, as well as strategic programs in oncology, Vir is committed to advancing medical science and delivering transformative medicines efficiently. The company is supported by an experienced leadership team proficient in progressing product candidates through various stages of research to commercialization.

📋 Description

• Write and edit a wide range of regulatory documents • Perform independent QC reviews of documents produced by the regulatory writing function • Verify the accuracy and internal/external consistency of documents • Define and confirm the scope of QC activities with document authors • Review documents for adherence to applicable style guides • Proofread and copyedit text to ensure clarity and accuracy • Support preparation and inspection‑readiness of technical documents • Communicate QC findings clearly and constructively to stakeholders • Facilitate the efficient project management of individual document workflows • Contribute to the continuous improvement of QC tools, checklists, and processes

🎯 Requirements

• Bachelor’s degree and 5 plus years of relevant experience • Working knowledge of the industry and content of key eCTD documents • Understanding of drug development and regulatory submission processes • Exceptional attention to detail with strong analytical and critical‑thinking skills • Proven ability to manage multiple tasks and priorities in a deadline‑driven environment • Experience working cross‑functionally in collaborative team environments • Experience with electronic document management and publishing systems • Experience with project and timeline management systems

🏖️ Benefits

• Health insurance • Flexible work hours • Paid time off