Principal Scientist, Regulatory CMC
ImmunityBio, Inc.
August 15, 2026
On-site
Summit, NJ
Operations
Principal Scientist, Regulatory CMC
Responsibilities:
- Prepare and review Module 2 (QOS) and Module 3 documents per CTD guidance and company standards.
- Contribute to development of global CMC regulatory strategies.
- Assist with preparation/review of pharmacy manuals, protocols, CMC reports, and related documentation.
- Provide expert opinion on CMC topics.
- Contribute to design of CMC protocols.
- Coordinate with other groups to address CMC-related matters.
- Assist with responses to Health Authority comments/questions on CMC issues.
- Train others on Regulatory Affairs SOPs, processes, and templates for document review, preparation, QC, and finalization.
- Perform ad-hoc/cross-functional duties as assigned.
Qualifications:
- Bachelor’s in life sciences/technical discipline + 10+ years relevant progressive experience; or
- Master’s + 8+ years; or
- Doctorate + 6+ years.
- Required: experience preparing CMC modules in eCTD format.
- Required: familiarity organizing responses to Health Authority requests.
- Preferred: familiarity with regulatory submissions outside the US.
Skills/Abilities:
- Knowledge of Health Authority procedures, guidance, document management, and electronic submissions.
- Proficient with Electronic Document Management Systems.
- Ability to meet deadlines; adapt to changing priorities.
- Strong organizational, written/oral communication, and attention to detail.
- Preferred: knowledge of biologic-based drugs (cell therapies, gene therapies, antibodies, recombinant proteins).
Benefits/Compensation (if applicable):
- Discretionary bonus and equity award.
- Annual base pay range: $170,000–$187,000.
Application instructions:
- Application window closes ~60 days from posting (or sooner if filled/closed).
Responsibilities:
- Prepare and review Module 2 (QOS) and Module 3 documents per CTD guidance and company standards.
- Contribute to development of global CMC regulatory strategies.
- Assist with preparation/review of pharmacy manuals, protocols, CMC reports, and related documentation.
- Provide expert opinion on CMC topics.
- Contribute to design of CMC protocols.
- Coordinate with other groups to address CMC-related matters.
- Assist with responses to Health Authority comments/questions on CMC issues.
- Train others on Regulatory Affairs SOPs, processes, and templates for document review, preparation, QC, and finalization.
- Perform ad-hoc/cross-functional duties as assigned.
Qualifications:
- Bachelor’s in life sciences/technical discipline + 10+ years relevant progressive experience; or
- Master’s + 8+ years; or
- Doctorate + 6+ years.
- Required: experience preparing CMC modules in eCTD format.
- Required: familiarity organizing responses to Health Authority requests.
- Preferred: familiarity with regulatory submissions outside the US.
Skills/Abilities:
- Knowledge of Health Authority procedures, guidance, document management, and electronic submissions.
- Proficient with Electronic Document Management Systems.
- Ability to meet deadlines; adapt to changing priorities.
- Strong organizational, written/oral communication, and attention to detail.
- Preferred: knowledge of biologic-based drugs (cell therapies, gene therapies, antibodies, recombinant proteins).
Benefits/Compensation (if applicable):
- Discretionary bonus and equity award.
- Annual base pay range: $170,000–$187,000.
Application instructions:
- Application window closes ~60 days from posting (or sooner if filled/closed).