Senior Manager, Regulatory Operations

Vir Biotechnology•San Francisco, CA

6d•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 Senior Manager, Regulatory Operations, who will report into the Senior Director of Regulatory Operations. In this role you will lead day-to-day regulatory operations activities with a high degree of independence. These include the preparation and compilation of submissions for regulatory agencies across assigned clinical studies and programs, management of regulatory submission processes and timelines, and oversight of regulatory tracking tools, archives, and infrastructure. The Senior Manager will serve as a subject matter expert and key resource for the regulatory operations team, working collaboratively with Regulatory Affairs leadership and cross-functional partners to ensure timely, high-quality submissions that meet global regulatory standards. This role is located in our San Francisco headquarters with an expectation of at least 3 days per week in office.

Requirements

Bachelor's degree in a life science or relevant discipline with 10+ years of relevant experience
Extensive experience successfully managing the creation and submission of regulatory documents
Strong working knowledge of electronic documents and submission standards and requirements relevant to US, EU and global regulatory environments
Advanced skills in the use of MS Word, Adobe Acrobat, and other publishing tools as well as regulatory document management systems such as Veeva Vault
Demonstrated expertise in eCTD, SPL, and NeeS submission formats
Proven project management skills to support on-time compilation and publishing of regulatory submissions, particularly larger and more complex submissions
Excellent communication and interaction skills, and ability to work collaboratively and independently with internal and external partners (publishing vendors, CROs, etc.)
Strong attention to detail and ability to manage multiple priorities simultaneously
Demonstrated ability to work independently with minimal supervision and exercise sound judgment in decision-making

Responsibilities

Lead and manage complex submission projects in conjunction with Regulatory Affairs and contributing departments across multiple programs
Manage submission preparation, transmission and archival ensuring adherence with internal processes and regional standards (US, EU, and global)
Manage and optimize submission content templates and enforcement of Company Style Guide
Lead submission formatting and publishing activities to meet deadlines and high-quality standards (SPL, eCTD, NeeS)
Track regulatory commitments for assigned products and work independently with Regulatory Affairs to ensure routine and periodic reporting requirements are met
Provide subject matter expertise for the formatting, management, and technical requirements of submission documents
Support vendor coordination and oversight for regulatory operations activities
Mentor and provide guidance to junior regulatory operations staff as needed
Contribute to the development and maintenance of internal document and submission standards
Support document management systems maintenance and provide user training during the submission process
Ensure documents meet global and regional technical/electronic document requirements and maintain compliance with HA inspection standards