ImmunityBio
Veeva RIM Specialist
Summit, NJ
Sponsorship not specifiedDetected 30 days ago
FDA RegulatoryCommunicationCollaborationOrganizational SkillsGxPRegulatory Affairs
About the role
- Execute the upload, tracking, life cycle maintenance of regulatory submissions, including INDs, BLAs, CTAs, for US and ex-US regions within Veeva RIM.
- Track all regulatory meetings, questions, information requests, and responses ensuring proper linking within Veeva RIM.
- Assist in responding to internal audits, health authority inspections, and regulatory inquiries related to RIM documentation.
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.
- This role is hands on and execution focused, working closely with all of regulatory affairs to support all US and ex-US regulatory activities and maintain inspection-ready system.
- Create and maintain electronic project folders for projects.
- Configure Vault objects, lifecycles, workflows, document types, and metadata to support business processes.
- Provide technical and functional support for users including, but not limited to, access to Veeva RIM
- Partner with regulatory affairs, IT, and clinical teams to translate business requirements into technical solutions.
- Assist in training Regulatory Documentation Specialists, ensuring that all SOPs are followed, and all questions are answered; Continue to provide support and assist in questions after the training is completed.
- Provide day-to-day support to system users.
- Collaborate with other Regulatory Documentation Specialists regarding upgrades to existing software programs, new software programs, or removing software programs that are no longer needed.
Requirements
- Bachelor's Degree in life sciences or technical discipline with 5+ years of regulatory operations experience in the biotechnology or pharmaceutical industry required
- High School diploma with 9+ years' experience required.
- Hands on experience with Veeva RIM and Veeva Vault required.
- Ability to work with firm deadlines and adapt quickly to changing requirements and priorities.
Skills
- Knowledge, Skills, & Abilities
Compensation
- The hourly base pay range for this position is below.
Benefits
- Maintain Veeva RIM by uploading all submissions, Health Authority correspondence, etc.
- Ensure that all working files, forms, sign-out sheets, and archives are organized and maintained in accordance with SOPs and Health Authority requirements.
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.