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Specialist III, Regulatory Lifecycle Maintenance

ImmunityBio

Summit, New Jersey, United States Full time July 01, 2026
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Vacancy Description

Position Summary

The Specialist III, Regulatory Lifecycle Maintenance is responsible for assisting in the development of global clinical regulatory strategy for investigational and marketed products and assists with the preparation of dossiers in eCTD format. This role will provide a high level of expertise to the organization in ensuring the conduct of clinical trials conform to Health Authority requirements.

Essential Functions

  • Prepare or review documents including investigator brochures, protocols, clinical study reports , annual reports, DSURs, PAERs, clinicaltrials.gov entries, and other lifecycle maintenance documents.
  • Compile, organize, and catalogue essential regulatory documents on all active clinical studies to maintain compliance with Health Authorities.
  • Review, edit and approve all final submissions to Health Authorities.
  • Assist in daily operations outside of essential BLAs and provide regulatory input on ...
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