Ensure conformance with health authority requirements
Coordinate electronic common technical document (ectd) modules
ImmunityBio, Inc. is seeking a Regulatory Documentation Specialist III to support document management and publishing in accordance with Health Authority requirements for their biotechnology products. The ideal candidate should have significant regulatory operations experience within the biotechnology or pharmaceutical industry, particularly in document management and electronic submissions
Job Summary
The Specialist III, Regulatory Documentation will provide expertise and guidance in the management and publishing of documents ensuring their conformance with Health Authority requirements.
This position will assist staff in the document management, publishing, and coordination of Electronic Common Tech Document (eCTD) modules.
ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines.
Matching Summary
Match Score: 85
ImmunityBio, Inc. is seeking a Regulatory Documentation Specialist III to support document management and publishing in accordance with Health Authority requirements for their biotechnology products. The ideal candidate should have significant regulatory operations experience within the biotechnology or pharmaceutical industry, particularly in document management and electronic submissions.
Salary
Base: $50.48 - $55.53 per hour; Bonus/Equity: discretionary bonus and equity award; Benefits: Medical, Dental and Vision Plan Options, 401(k) Retirement Plan with Company Match, Unlimited PTO (Exempt)
Skills & Requirements
Must-have
Manage and publish regulatory documents
Ensure conformance with Health Authority requirements
Coordinate Electronic Common Technical Document (eCTD) modules
Maintain Veeva RIM
Format documents according to style guides and agency requirements
Quality control of documents
Nice-to-have
Harness and amplify the immune system
Collaborative team environment
Professional development opportunities
Key Requirements
5+ years of regulatory operations experience
Bachelor's Degree in life sciences or technical discipline
Expert knowledge of Health Authority procedures
Expert knowledge of Electronic Document Management Systems