Website Vir Biotechnology
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.
We are seeking a highly talented Director to lead the clinical regulatory strategy for programs in our hepatitis D 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 Global Regulatory Lead 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.
RESPONSIBILITIES AND LEARNING OPPORTUNITIES:
- Develop global regulatory strategy that meets program objectives.
- Develop global regulatory submission plan including filing requirements and timelines.
- Interact with cross-functional program team to develop and review submission content and manage HA interactions including requests for information.
- Where appropriate, liaise with joint development teams and regulatory experts at partner companies and/or 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 a track record of 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.
- Thorough 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.
- Excellent written and verbal communication with strong track record of collaboration.
This role may be performed remotely if VIR can support remote work arrangements in the state where you currently reside. This includes most states within the US. If you move forward in the hiring process, VIR recruiters will discuss options with you.
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 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.
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