Vir Biotechnology is a commercial-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus. For more information, please visit www.vir.bio .
We believe the success of our colleagues drives the success of our Mission. We have an ongoing commitment to creating a company passionate about equality, inclusion, and respect. When everyone feels supported and encouraged to give at their best, we will collectively deliver outstanding results.
Vir is seeking Senior Specialist of Regulatory Affairs (Clinical / Nonclinical and CMC) to join the regulatory group. The successful candidate, under the guidance of experienced regulatory affairs professionals, will be responsible for preparing and submitting routine regulatory submissions as well as working with their Supervisor on obtaining approval of regulatory submissions through interactive communication with global Health Authorities, including the US FDA.
- Review and prepare routine (e.g., investigator submissions, correspondence to FDA, etc.) regulatory submissions as well as support senior-level staff in the preparation, QC, and submission of major submissions (initial INDs, NDAs, BLAs)
- Assists in regulatory interactions including clarification and follow-up with health authorities
- Regulatory Intelligence (research regulations, guidance, precedence) responsibilities as assigned by Supervisor
- Coordinate and support the team in planning and preparation for FDA/Health Authority meetings or teleconferences
- 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
- Contribute to the development and maintenance of the Regulatory Affairs working practices and procedures
- Performs document filing and retrieval functions as directed, or in conjunction with departmental working practices and company SOPs
QUALIFICATIONS AND EXPERIENCE:
- 5 years preferred of regulatory experience in the pharmaceutical or biopharmaceutical industry
- 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
- Location: United States Remote
- B.S./ M.S, preferably in a scientific/technical discipline
Vir'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 benefits and perks such as: health, dental, vision, life and disability insurance benefits, non-accrual paid time off, one Friday a month paid-time off, company shut down for holidays, commuter benefits, child care reimbursement, education reimbursement, 401K match and lunch for all lab essential personnel!
Vir is an equal opportunity employer. We value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment. Please contact Human Resources to request accommodation.
Vir Human Resources leads recruitment and employment for Vir. Unsolicited resumes sent to Vir from recruiters do not constitute any type of relationship between the recruiter and Vir and do not obligate Vir 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.