Position Summary

The Senior Scientist, Regulatory CMC will assist in the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategy for investigational and marketed products and manage the preparation of dossiers in eCTD format. The Principal Scientist will interact with cross-functional teams on CMC regulatory strategy and regional regulatory requirements and interact with CMC subject matter experts (SMEs). This position will support the development of submission strategies for CMC modules and updates, including life cycle management; and generation of submission-ready content for the Quality/CMC sections of all clinical trial and marketing authorization applications for ImmunityBio, Inc.

Essential Functions