Regulatory Documentation Specialist Ii

Nantomics Inc

Summit, New Jersey, United States
$45.66 - $50.23 ph; discretionary bonus + equity a...
On-site (monday through friday)
Ectd module coordination
Veeva rim document management
Health authority requirements
ImmunityBio, Inc. is seeking a Regulatory Documentation Specialist II to assist in managing and publishing regulatory documents in compliance with Health Authority requirements. The ideal candidate will have experience in regulatory operations within the biotechnology or pharmaceutical industry, with strong organizational skills and attention to detail

Job Summary

  • The Specialist II, Regulatory Documentation will provide support in the management and publishing of documents ensuring its 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 II to assist in managing and publishing regulatory documents in compliance with Health Authority requirements. The ideal candidate will have experience in regulatory operations within the biotechnology or pharmaceutical industry, with strong organizational skills and attention to detail.

Salary

$45.66 - $50.23 per hour; Discretionary bonus and equity award; Medical, Dental, Vision, 401(k) with match, Unlimited PTO (Exempt)

Skills & Requirements

Must-have

  • eCTD module coordination
  • Veeva RIM document management
  • Health Authority requirements
  • Electronic submission publishing
  • Document formatting and compilation

Nice-to-have

  • Harnessing the human immune system
  • Conquering cancer and infectious diseases
  • Professional development opportunities

Key Requirements

  • Bachelor's Degree in life sciences or technical discipline with 2+ years of regulatory operations experience
  • High school diploma with 6+ years of regulatory operations experience
  • Working knowledge of Veeva Vault especially Veeva RIM
  • Working knowledge of Electronic Document Management Systems
  • Working knowledge of Health Authority procedures

Work Rights

Not specified

Tailored Resume

Cover Letter