Senior Scientist, Regulatory CMC
ImmunityBio, Inc.
August 15, 2026
On-site
Summit, NJ
Corporate Functions
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 preparation of dossiers in eCTD format. Supports submission strategy for CMC modules/updates, including life cycle management, and generates submission-ready content for Quality/CMC sections of clinical trial and marketing authorization applications.
Essential Functions:
- Prepare and review Module 2 (QOS) and Module 3 documents per CTD guidance and company standards.
- Support development of global CMC regulatory strategies.
- Assist in preparation/review of pharmacy manuals, protocols, CMC reports, and related documentation.
- Provide input and recommendations on CMC topics.
- Support design of CMC protocols.
- Interact with other groups to address CMC matters.
- Assist with responses to Health Authority comments/questions on CMC issues.
- May train others on Regulatory Affairs SOPs/processes/templates.
- Perform ad-hoc cross-functional duties/projects.
Education & Experience:
- BS in life sciences/technical discipline with 6+ years; or MS with 4+ years; or Doctorate with 2+ years.
- Experience preparing CMC modules for eCTD submissions (required).
- Familiarity organizing responses to Health Authority requests (required).
- Familiarity with non-US regulatory submissions (bonus).
Knowledge, Skills & Abilities:
- Health Authority procedures/guidance for document management and electronic submission.
- Health Authority CMC guidance and requirements.
- Proficient in Electronic Document Management Systems.
- Works to firm deadlines; adapts to changing priorities.
- Strong organizational skills; written/oral communication; attention to detail.
- Knowledge of biologic-based drugs (cell therapies, gene therapies, antibodies, recombinant proteins) desired.
Benefits (eligible):
- Discretionary bonus and equity award.
Application instructions:
- Application window anticipated to close 60 days from posting or sooner if filled/closed.
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 preparation of dossiers in eCTD format. Supports submission strategy for CMC modules/updates, including life cycle management, and generates submission-ready content for Quality/CMC sections of clinical trial and marketing authorization applications.
Essential Functions:
- Prepare and review Module 2 (QOS) and Module 3 documents per CTD guidance and company standards.
- Support development of global CMC regulatory strategies.
- Assist in preparation/review of pharmacy manuals, protocols, CMC reports, and related documentation.
- Provide input and recommendations on CMC topics.
- Support design of CMC protocols.
- Interact with other groups to address CMC matters.
- Assist with responses to Health Authority comments/questions on CMC issues.
- May train others on Regulatory Affairs SOPs/processes/templates.
- Perform ad-hoc cross-functional duties/projects.
Education & Experience:
- BS in life sciences/technical discipline with 6+ years; or MS with 4+ years; or Doctorate with 2+ years.
- Experience preparing CMC modules for eCTD submissions (required).
- Familiarity organizing responses to Health Authority requests (required).
- Familiarity with non-US regulatory submissions (bonus).
Knowledge, Skills & Abilities:
- Health Authority procedures/guidance for document management and electronic submission.
- Health Authority CMC guidance and requirements.
- Proficient in Electronic Document Management Systems.
- Works to firm deadlines; adapts to changing priorities.
- Strong organizational skills; written/oral communication; attention to detail.
- Knowledge of biologic-based drugs (cell therapies, gene therapies, antibodies, recombinant proteins) desired.
Benefits (eligible):
- Discretionary bonus and equity award.
Application instructions:
- Application window anticipated to close 60 days from posting or sooner if filled/closed.