Senior Director, Regulatory Writing - Remote

Overview

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.

In Short

• Lead the development of clear, accurate, and compliant regulatory documents for global health authorities.
• Author and oversee critical regulatory documents including Clinical trial protocols and amendments.
• Serve as the regulatory writing lead for high-priority programs.
• Analyze complex scientific and medical information and translate it into clear language.
• Work closely with cross-functional teams to gather data and ensure comprehensive documentation.
• Drive continuous improvement in regulatory writing processes and standards.
• Analyze and synthesize complex scientific data to create compelling regulatory narratives.

Requirements

• Bachelor's Degree in Life Sciences with 18+ years of regulatory writing experience.
• Experience with regulatory documents such as CSRs, IBs, and protocols.
• Deep knowledge of eCTD structure and ICH guidelines.
• Involvement with marketing applications, preferably including responses to questions.
• Proven ability to work independently on complex projects.
• Minimum 10 years as a lead regulatory writer with increasing complexity of assignments.

Benefits

• Competitive salary and bonus structure.
• Comprehensive health and welfare benefit plans.
• Non-accrual paid time off and company shutdown for holidays.
• 401K match and daily lunch in the office.