Manager, Regulatory Affairs

THE OPPORTUNITY

Vir Biotechnology is looking for a Regulatory Affairs Manager to join the regulatory group. The successful candidate, under the guidance of experienced regulatory affairs professionals, will be responsible for the coordination and preparation of documents intended for regulatory submissions for new and mature products (as applicable) to ensure alignment and compliance with local and regional registration requirements as well as with company policies.

This role is based in San Francisco and requires 3 days a week onsite.

WHAT YOU'LL DO

• you will represent Regulatory Affairs on cross-functional project teams with the following responsibilities:
• Coordinate documents intended for regulatory submissions, manage internal reviews and resulting input from cross‑functional team members for products in line with ICH and regional requirements, meets scientific rigor and company policies and procedures
• Ensures quality and regulatory standards are considered and upheld throughout the product development life cycle
• Assists with the coordination and tracking of regulatory commitments and submission plans for maintenance activities such as INDs/CTAs, annual reports, periodic safety reports, protocol submissions, and key regulatory filings
• Participates in group meetings and provides tactical approaches to addressing issues of moderate complexity
• Participate in the development of processes and procedures relevant to regulatory functions
• Performs document filing and retrieval functions as directed, or in conjunction with departmental SOPs

WHO YOU ARE AND WHAT YOU BRING

• BS and 8+ years of Experience, MS and 6+ years of experience with a minimum of 5+ years of regulatory experience
• Working knowledge of US FDA regulations (ex-US is a plus) and industry standards pertaining to regulatory
• Knowledge of the drug development process and eCTD
• Excellent organization skills and ability to work on multiple projects with tight timelines
• Excellent verbal and written communication skills and interpersonal skills