Senior Manager, Regulatory Operations

Support vendor coordination and oversight for regulatory operations activities

Ensure documents meet global and regional technical/electronic document requirements and maintain compliance with HA inspection standards

The expected salary range for this position is $142,500 to $199,000 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, 401K match and lunch each day in the office.

Applicants must currently be authorized to work for any employer in the U.S.  We are unable to sponsor or take over sponsorship of an employment Visa at this time.

All employment decisions at Vir Biotechnology are based on legitimate, non-discriminatory business requirements, job duties and individual qualifications. Employment decisions are made without regard to any legally protected characteristics.

This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs.  Vir Biotechnology also strongly commits to providing employees with a work environment free of unlawful conduct or harassment.

Vir Biotechnology Human Resources leads recruitment and employment for Vir Biotechnology. Unsolicited resumes sent to the company from recruiters do not constitute any type of relationship between the recruiter and Vir Biotechnology and do not obligate us to pay fees should we hire from those resumes. We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring manager or employees.

Vir Biotechnology is looking for a Senior Manager, Regulatory Operations, who will report into the Senior Director of Regulatory Operations.

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.

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