Vir Biotechnology (Vir), a San Francisco based company focused on infectious diseases seeks a highly talented Principal Regulatory Program Lead. You will take responsibility for planning of regulatory strategy, preparation and management Health Authority meetings and oversight of submission planning and execution for development regulatory activities on one or more Vir’s programs. You will work closely with the clinical and non-clinical members of the Program Team to meet program objectives, and be supported by a team of medical writers and CMC regulatory experts.
Develop regulatory strategy that meets program objectives.
Develop 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 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.
Practical experience in infectious disease applications. Experience with vaccine and monoclonal antibodies a plus.
Experience managing written and verbal communication with Health Authorities.
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. Ability to effectively present to and influence Senior Management.
Ability to effectively present to and influence Senior Management.
BS or MS degree in applicable scientific or business disciplines.