Principal Specialist, Health Authorities

ImmunityBio, Inc.

Summit, New Jersey, United States
Base: $170,000 to $187,000 annually; bonus/equity:...
On-site
Clinical regulatory strategy
Submission packages
Health authority requirements
ImmunityBio, Inc. is seeking a Principal Specialist, Health Authorities to assist in developing global clinical regulatory strategies and preparing submission packages for health authorities. The ideal candidate will have extensive experience in regulatory submissions, particularly in clinical research, and will thrive in a collaborative environment

Job Summary

  • Assist in the development of global clinical regulatory strategy for investigational and marketed products and assist with the preparation, review, and finalization of submission packages and responses to Health Authorities.
  • Evaluate clinical data, reports, and summaries for compliance with the protocol, statistical analysis plan, monitoring guidelines, data management plan, and any other clinical trial associated document.
  • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.

Matching Summary

Match Score: 85

ImmunityBio, Inc. is seeking a Principal Specialist, Health Authorities to assist in developing global clinical regulatory strategies and preparing submission packages for health authorities. The ideal candidate will have extensive experience in regulatory submissions, particularly in clinical research, and will thrive in a collaborative environment.

Salary

Base: $170,000 to $187,000 annually; Bonus/Equity: discretionary bonus and equity award; Benefits: Medical, Dental and Vision Plan Options, Health and Financial Wellness Programs, EAP, Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability, FSAs, 401(k) with Company Match, 529 Program, Voluntary Legal Services, Identity Theft Protection, Pet Insurance, Employee Discounts, Rewards and Perks, PTO (11 Holidays, Unlimited PTO for Exempt, 10 Vacation Days, 56 Hours Health Pay, 2 Personal Days, 1 Cultural Day for Non-Exempt)

Skills & Requirements

Must-have

  • clinical regulatory strategy
  • submission packages
  • Health Authority requirements
  • eCTD format
  • clinical data evaluation

Nice-to-have

  • cross-functional duties
  • emerging Health-Authority guidance
  • collaborative team environment

Key Requirements

  • Bachelor’s Degree in life sciences or technical discipline with 10+ years of experience
  • Master’s degree in life sciences or technical discipline with 8+ years of experience
  • Experience in preparation of clinical modules in eCTD format
  • Familiarity with organizing responses to Health Authority information requests

Work Rights

Not specified

Tailored Resume

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