ImmunityBio

ImmunityBio

Regulatory Documentation Specialist III

Summit, NJ · Mid

Sponsorship not specifiedDetected 31 days ago
FDA RegulatoryCommunicationOrganizational Skills

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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

  • Serve as an advisor to internal departments in the preparation and submission of regulatory documentation
  • Strong knowledge in Veeva Vault especially Veeva RIM

Responsibilities

  • Create and maintain electronic project folders for projects
  • 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
  • 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.
  • Generate electronic files for working documents
  • Format documents prepared or received according to stipulated style guides for reports, assessments, regulatory submissions, letters, etc.
  • Format and compile documents according to requirements specified by Regulatory Agencies
  • QC documents (formatting, bookmarking, hyperlinking, document ) that were prepared by others
  • Create new submissions in submission software following all SOPs and ensuring all checklists are completed
  • Publish documents (internal bookmarks and hyperlinks), insert into XML backbone (docuBridge), and complete external hyperlinks to other documents and datasets on the XML backbone

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 of regulatory operations experience in the biotechnology or pharmaceutical industry required
  • Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
  • Bachelor's Degree in life sciences or technical discipline with 5+ years of regulatory operations experience in the biotechnology or pharmaceutical industry required; or

Skills

  • Knowledge, Skills, & Abilities
  • Strong organizational skills, written and oral communication skills, and attention to detail

Compensation

  • The hourly base pay range for this position is below.

Benefits

  • Submit documents to Health Authorities.
  • Ensure that all working files, forms, signout sheets, and archives are organized and maintained in accordance with SOPs and Health Authority requirements
  • Expert knowledge of Health Authority procedures and guidance regarding document management and electronic submission

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.