Associate Director, Regulatory Cmc

ImmunityBio, Inc.

Summit, NJ, United States
Base: $200,000 to $220,000 annually; bonus/equity:...
**
Develop global cmc regulatory strategy
Manage ectd dossier preparation
Expert opinion on cmc topics
** ImmunityBio, Inc. is seeking an Associate Director of Regulatory CMC to develop global Chemistry, Manufacturing, and Control regulatory strategies for investigational and marketed products. The ideal candidate will possess extensive experience in regulatory submissions, particularly in CMC modules, and will manage a team while collaborating with cross-functional groups. **

Job Summary

  • The Associate Director, Regulatory CMC will assist in the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategy for investigational and marketed products and manage preparation of dossiers in eCTD format.
  • Key responsibilities will include the development of Health Authority submission strategies for CMC modules and updates, including life cycle management; and generation of submission-ready content for the Quality/CMC sections of all clinical trial and marketing authorization applications for ImmunityBio, Inc.
  • ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families.

Matching Summary

Match Score: 75

** ImmunityBio, Inc. is seeking an Associate Director of Regulatory CMC to develop global Chemistry, Manufacturing, and Control regulatory strategies for investigational and marketed products. The ideal candidate will possess extensive experience in regulatory submissions, particularly in CMC modules, and will manage a team while collaborating with cross-functional groups. **

Salary

Base: $200,000 to $220,000 annually; Bonus/Equity: discretionary bonus and equity award; Benefits: Medical, Dental and Vision Plan Options, Health and Financial Wellness Programs, EAP, Life/AD&D, Disability, FSAs, 401(k) with Match, 529 Program, Legal Services, Identity Theft Protection, Discounts, PTO

Skills & Requirements

Must-have

  • Develop global CMC regulatory strategy
  • Manage eCTD dossier preparation
  • Expert opinion on CMC topics
  • Generate submission-ready content
  • Respond to Health Authority comments

Nice-to-have

  • Harness and amplify the immune system
  • Collaborative team environment
  • Professional development opportunities
  • Experience with regulatory submissions outside US

Key Requirements

  • 10+ years relevant progressive experience with Bachelor's
  • 8+ years relevant progressive experience with Master's
  • 6+ years relevant progressive experience with Doctorate
  • Experience managing and preparing CMC modules in eCTD format
  • Experience organizing responses to Health Authority requests
  • Experience managing staff preferred

Work Rights

Not specified

Tailored Resume

Cover Letter