Vir Biotechnology, Inc.
Manager, Regulatory Affairs-Document Coordinator
Vir Biotechnology, Inc., San Francisco, California, United States, 94199
Manager, Regulatory Affairs-Document Coordinator
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. 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 Who We Are And What We Offer
The expected salary range for this position is $121,500 to $170,500 per year. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors. Vir Biotechnology's compensation and benefits are aligned with the current market and commensurate with the person's experience and qualifications. All full-time employees receive a package that includes compensation, bonus and equity as well as many other Vir Biotechnology benefits and perks such as health and welfare benefit plans, non-accrual paid time off, company shut down for holidays, commuter benefits, childcare reimbursement, education reimbursement, 401K match and lunch each day in the office.
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. 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 Who We Are And What We Offer
The expected salary range for this position is $121,500 to $170,500 per year. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors. Vir Biotechnology's compensation and benefits are aligned with the current market and commensurate with the person's experience and qualifications. All full-time employees receive a package that includes compensation, bonus and equity as well as many other Vir Biotechnology benefits and perks such as health and welfare benefit plans, non-accrual paid time off, company shut down for holidays, commuter benefits, childcare reimbursement, education reimbursement, 401K match and lunch each day in the office.