Manager, Regulatory Affairs

Vir Biotechnology•San Francisco, CA

13h•Hybrid

About The Position

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. 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.

Requirements

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

Responsibilities

Represent Regulatory Affairs on cross-functional project teams
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