ImmunityBio

ImmunityBio

Veeva RIM Specialist

Summit, NJ · Mid

Sponsorship not specifiedDetected 14 days ago
FDA RegulatoryCommunicationCollaborationOrganizational SkillsGxPRegulatory Affairs

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odds of building a lasting career here

37Risky
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70

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Employer immigration record

from this employer's Department of Labor filings

Files H-1B transfers

1 transfer filing in the last year, covering 1 worker. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.

Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.

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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

  • 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.
  • Performs ad-hoc and cross-functional duties and/or projects, as assigned, to support business needs and provide developmental opportunities.
  • Upload and manage Word and source documents in Veeva Vault to support collaboration, version control, and document updates.

Requirements

  • Bachelor's Degree in life sciences or technical discipline with 4+ years of regulatory operations experience in the biotechnology or pharmaceutical industry required
  • High School diploma with 8+ years of regulatory operations experience in the biotechnology or pharmaceutical industry 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.

Company info

  • We are committed to equal employment opportunity and ensure that all candidates are assessed based on their qualifications, skills, and experience through human review.
  • At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace.

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.