Manager, Regulatory Lifecycle Maintenance

ImmunityBio, Inc.

Summit, New Jersey, United States
Base: $165,000 to $181,000 annually; bonus/equity:...
On-site
Global clinical regulatory compliance
Ectd format
Clinical submissions
ImmunityBio, Inc. is seeking a Manager for Regulatory Lifecycle Maintenance to oversee clinical regulatory compliance for investigational and marketed products. The role involves managing staff, ensuring adherence to Health Authority requirements, and maintaining clinical trial documentation

Job Summary

  • The Manager, Lifecycle Maintenance will advance the maintenance global clinical regulatory compliance for investigational and marketed products and manage the maintenance of study files in eCTD format.
  • This position will contribute to the organization in the design and conduct of clinical trials in conformance with Health Authority requirements and the management of clinical trial documentation to support clinical submissions.
  • 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 Manager for Regulatory Lifecycle Maintenance to oversee clinical regulatory compliance for investigational and marketed products. The role involves managing staff, ensuring adherence to Health Authority requirements, and maintaining clinical trial documentation.

Salary

Base: $165,000 to $181,000 annually; Bonus/Equity: discretionary bonus and equity award; Benefits: Medical, Dental and Vision Plan Options, Health and Financial Wellness Programs, Employer Assistance Program (EAP), Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability, Healthcare and Dependent Care Flexible Spending Accounts, 401(k) Retirement Plan with Company Match, 529 Education Savings Program, Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks, Paid Time Off (PTO) includes: 11 Holidays, Unlimited PTO for Exempt Employees, 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day for Non-Exempt Employees

Skills & Requirements

Must-have

  • global clinical regulatory compliance
  • eCTD format
  • clinical submissions
  • Health Authority guidance documents
  • clinical research GCP

Nice-to-have

  • harness and amplify the immune system
  • transform the lives of patients
  • professional development opportunities
  • cross-functional teams

Key Requirements

  • 7+ years relevant progressive experience with Bachelor's
  • 5+ years relevant progressive experience with Master's
  • 3+ years relevant progressive experience with Doctorate
  • Experience managing staff preferred
  • Experience with eCTD format
  • Experience with Health Authority information requests

Work Rights

Not specified

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