Senior Director, Regulatory Affairs

Vir Biotechnology, Inc.
is an immunology company focused on combining cutting-edge technologies to treat and prevent infectious diseases and other serious conditions.
Vir has assembled two technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes.
Its current clinical development pipeline consists of product candidates targeting hepatitis B and hepatitis delta viruses and human immunodeficiency virus.
Vir has several preclinical candidates in its pipeline, including those targeting influenza A and B, COVID-19, RSV/MPV and HPV.
We believe the success of our colleagues drives the success of our mission.
We are committed to creating a company passionate about equality, inclusion, and respect.
When everyone feels supported and encouraged to give their best, we will collectively deliver outstanding results.
We are proud to be the first company to be ranked at the top of the Deloitte Fast 500 list two years in a row (2023 & 2022)! Job Summary: Vir is seeking a Senior Director-level candidate to lead the clinical/nonclinical regulatory strategy for programs in our development portfolio.
You will take responsibility for planning of the global regulatory strategy, preparation and management of health authority meetings in addition to oversight of submission planning and execution.
You will work closely with the Program Executive and clinical and non-clinical team members to meet program objectives, and be supported by a team of regulatory managers, medical writers, regulatory operations and regulatory CMC experts.
As applicable, you will also be the primary regulatory contact for external partners.
This role reports to the Vice President of Regulatory Affairs.
RESPONSIBILITIES: Develop global regulatory strategy that meets program objectives Develop global regulatory submission plan including filing requirements and timelines Interact with program teams to develop and review submission content and manage HA interactions including requests for information Liaise with joint development teams and regulatory experts at partner companies and CROs Ensure compliance with submission maintenance requirements (Safety reporting, Annual Reports, Investigator Updates) Ensure compliance with internal SOPs and policies regarding regulatory operations, document management and communication Qualifications and Experience: 12+ years' experience in pharmaceutical product development including experience leading regulatory teams to successful filings including IND/CTA and/or NDA/BLAs BS or MS degree in applicable scientific or business disciplines Practical experience in infectious disease applications.
Experience with oligonucleotide or monoclonal antibody products a plus Experience managing written and verbal communication with health authorities Leadership in health authority meetings a plus Understanding of major FDA, EMA, ICH guidelines Familiarity with eCTD format and lifecycle management Global filing experience desired (US, EU, CA, Aus, NZ).
Working knowledge of Japan, China, LATAM procedures a plus A strong track record of collaboration #LI-225024411_AA1 #LI-Remote The expected salary range for this position is $217,000.
00 to $318,000.
00.
Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.
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, company shut down for holidays, commuter benefits, child care reimbursement, education reimbursement, 401K match and lunch for all onsite employees! Vir Biotechnology ("Vir") is an equal opportunity employer.
All employment decisions at Vir are based on legitimate, non-discriminatory business requirements, job duties and individual qualifications.
Employment decisions are made without regard to race, color, religion, sex (including pregnancy), gender, gender identity, gender expression, sexual orientation, age, parental status, marital status, national origin, ancestry, disability, medical condition, genetic information (including family medical history), political affiliation, military service or any other legally protected characteristic.
This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs.
Vir also strongly commits to providing employees with a work environment free of unlawful discrimination or harassment.
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.
For hires based in the United States, Vir Biotechnology, Inc.
, participates in E-Verify.
Candidate Privacy Notice