Senior Scientist, Regulatory Cmc

ImmunityBio, Inc.

Summit, NJ, United States
Base: $140,000 - $154,000 annually; bonus/equity: ...
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Ectd format submission experience
Cmc regulatory strategy
Health authority guidance documents
** ImmunityBio, Inc. is seeking a Senior Scientist in Regulatory CMC to develop global regulatory strategies for investigational and marketed products. The ideal candidate should have significant experience in CMC submissions in eCTD format and a strong understanding of regulatory requirements, particularly in the biotechnology sector. **

Job 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.
  • 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.
  • ImmunityBio offers a competitive total rewards benefits package including Medical, Dental and Vision Plan Options, 401(k) Retirement Plan with Company Match, and Unlimited PTO for Exempt Employees.

Matching Summary

Match Score: 75

** ImmunityBio, Inc. is seeking a Senior Scientist in Regulatory CMC to develop global regulatory strategies for investigational and marketed products. The ideal candidate should have significant experience in CMC submissions in eCTD format and a strong understanding of regulatory requirements, particularly in the biotechnology sector. **

Salary

Base: $140,000 - $154,000 annually; Bonus/Equity: discretionary bonus and equity award; Benefits: Medical, Dental, Vision, 401(k) with match, Unlimited PTO (Exempt)

Skills & Requirements

Must-have

  • eCTD format submission experience
  • CMC regulatory strategy
  • Health Authority guidance documents
  • electronic submission procedures

Nice-to-have

  • Biologic-based drugs knowledge
  • international regulatory submissions

Key Requirements

  • Bachelor's Degree with 6+ years experience
  • Master's Degree with 4+ years experience
  • Doctorate degree with 2+ years experience
  • Experience with eCTD format
  • Familiarity with Health Authority requests

Work Rights

Not specified

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