Director, Global Labeling Regulatory
ImmunityBio, Inc.
August 20, 2026
On-site
Summit, NJ
Corporate Functions
Position Summary:
Director, Global Labeling Regulatory orchestrates global development, maintenance, and compliance of product labeling throughout a drug’s lifecycle; manages direct reports and partners cross-functionally to ensure investigational/marketed drug labeling meets global health authority requirements.
Essential Functions / Responsibilities:
- Manage creation/execution of global labeling strategies from early clinical through commercialization.
- Lead day-to-day team activities (hire/train, coach, monitor performance).
- Prepare/maintain key labeling documents (USPI, EU SmPC).
- Ensure labeling content/artwork complies with health authority regulations and GMP (monitor changes and implement updates).
- Manage updates to label content/artwork for packaging/supplies with manufacturing and third-party vendors.
- Review/approve label proofs from internal/external teams.
- Oversee/advise label content negotiations with Regulatory Agencies.
- Draft/lead responses to health authority comments/questions on labeling issues.
- Collaborate on global labeling/CMC matters; manage labeling change controls.
- Oversee/draft label technical specifications; may train Regulatory Affairs SOPs/templates.
- Perform ad-hoc/cross-functional projects as needed.
Education & Experience (Required/Preferred):
- Bachelor’s (14+ years) or Master’s (12+ years) in life sciences/technical discipline.
- Required: extensive Global Health Authority regulatory labeling experience (clinical + commercial).
- Plus: eCTD CMC module preparation/submission.
- Preferred: managing staff; Veeva Vault.
Skills/Knowledge:
- Biologic-based drug labeling expertise (cell/gene therapies, antibodies, recombinant proteins).
- Leadership, complex matrix experience, deadline management.
- Electronic document management proficiency; strong communication/organization; cultural sensitivity.
Benefits (as stated): Medical/Dental/Vision; wellness programs; EAP; life/AD&D; short/long-term disability; FSAs; 401(k) match; 529; PTO/holidays.
Application instruction:
Application window anticipated to close 60 days from posting (or sooner if filled/closed).
Director, Global Labeling Regulatory orchestrates global development, maintenance, and compliance of product labeling throughout a drug’s lifecycle; manages direct reports and partners cross-functionally to ensure investigational/marketed drug labeling meets global health authority requirements.
Essential Functions / Responsibilities:
- Manage creation/execution of global labeling strategies from early clinical through commercialization.
- Lead day-to-day team activities (hire/train, coach, monitor performance).
- Prepare/maintain key labeling documents (USPI, EU SmPC).
- Ensure labeling content/artwork complies with health authority regulations and GMP (monitor changes and implement updates).
- Manage updates to label content/artwork for packaging/supplies with manufacturing and third-party vendors.
- Review/approve label proofs from internal/external teams.
- Oversee/advise label content negotiations with Regulatory Agencies.
- Draft/lead responses to health authority comments/questions on labeling issues.
- Collaborate on global labeling/CMC matters; manage labeling change controls.
- Oversee/draft label technical specifications; may train Regulatory Affairs SOPs/templates.
- Perform ad-hoc/cross-functional projects as needed.
Education & Experience (Required/Preferred):
- Bachelor’s (14+ years) or Master’s (12+ years) in life sciences/technical discipline.
- Required: extensive Global Health Authority regulatory labeling experience (clinical + commercial).
- Plus: eCTD CMC module preparation/submission.
- Preferred: managing staff; Veeva Vault.
Skills/Knowledge:
- Biologic-based drug labeling expertise (cell/gene therapies, antibodies, recombinant proteins).
- Leadership, complex matrix experience, deadline management.
- Electronic document management proficiency; strong communication/organization; cultural sensitivity.
Benefits (as stated): Medical/Dental/Vision; wellness programs; EAP; life/AD&D; short/long-term disability; FSAs; 401(k) match; 529; PTO/holidays.
Application instruction:
Application window anticipated to close 60 days from posting (or sooner if filled/closed).