$106,500–$202,500
USD/year
Support regulatory approval of biologics drug substances by authoring Chemistry, Manufacturing, and Controls (CMC) filing content and by leading cross-functional CMC teams throughout Phase 1, Phase 2, and Phase 3 development. Author sections of regulatory documents, including INDs and BLAs, based on relevant source documentation. Partner with subject matter experts in various process development functions to ensure technical information is accurately transcribed into regulatory documents.