ImmunityBio
Senior Specialist, Regulatory Affairs
Summit, NJ · Senior · Full-time
Sponsorship not specifiedDetected 30 days ago
ComplianceProject ManagementFDA RegulatoryCommunicationOrganizational SkillsMicrosoft OfficeRegulatory Affairs
About the role
- Serve as a Regulatory Affairs subject matter expert to the Regulatory Affairs team and organization.
- Responsible for maintaining compliance with US and International Health Authority regulations for products under development and for marketed products.
- Keep abreast of internal and external changes, trends, and developments to the regulatory environment that may have an impact on ImmunityBio products.
Responsibilities
- ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells.
- Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow.
- Approve, review, or prepare common technical documents (CTD) for technical content and compliance with regulatory requirements
- Assist with developing and evaluating regulatory strategy
- Performs other special projects and duties as requested.
Requirements
- Bachelor's Degree in life sciences required with 7+ years of relevant regulatory compliance experience in pharmaceutical drug development required
- Master's Degree in life sciences required with 5+ years of relevant regulatory compliance experience in pharmaceutical drug development required.
- Knowledge and experience with organizing responses to Regulatory Authority requests required
- Knowledge of organizing responses to Regulatory Authority requests
- Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
- Bachelor's Degree in life sciences required with 7+ years of relevant regulatory compliance experience in pharmaceutical drug development required; or
Skills
- Knowledge, Skills, & Abilities
- Strong project management and computer skills (including Microsoft office)
- Strong organizational skills, written/oral communication skills and attention to detail
Compensation
- The annual base pay range for this position is below.
Visa & Work Authorization
- race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law
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This listing is sourced directly from ImmunityBio's careers page and normalized into a canonical job model.