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Principal Scientist, Global Labeling Regulatory

Company

ImmunityBio

Location

Summit, United States

Type

Full time

Position Summary

The Principal Scientist, Global Labeling will report to the Director, Global Labeling and be responsible for the strategic global development, maintenance, and compliance of product labeling throughout a drug's lifecycle. This expert will work with other cross-functional teams and SMEs to ensure that all labeling for investigational and marketed drugs meet the regulatory requirements of global health authorities. 

Essential Functions

  • Create and execute global labeling strategies from early clinical development through commercialization.
  • Contribute to writing and maintaining key labeling documents, such as US Prescribing Information (USPI), and the EU Summary of Product Characteristics (SmPC).
  • Ensure that all labeling content and artwork comply with international and local Health Authority regulations (e.g., FDA, EMA, MHRA etc.) and Good Manufacturing Practices (GMP). This includes monitoring for regulatory cha...

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