Senior Specialist, Regulatory Affairs

ImmunityBio, Inc.

Summit, NJ, United States
Base: $135,000 to $150,000 annually; bonus/equity:...
On-site
Regulatory compliance strategies
Health authority requirements
Common technical documents (ctd)
ImmunityBio, Inc. is seeking a Senior Specialist in Regulatory Affairs to ensure compliance with regulatory requirements in the development of their biotechnology products. The ideal candidate will have extensive experience in regulatory compliance, particularly in the pharmaceutical sector, and will contribute to the development of regulatory strategies

Job Summary

  • The Senior Specialist, Regulatory Affairs will provide expertise to the organization in the development of regulatory compliance strategies and in ensuring its conformance to Health Authority requirements.
  • Responsible for maintaining compliance with US and International Health Authority regulations for products under development and for marketed products.
  • ImmunityBio employees are as valuable as the people we serve, with robust benefit offerings to support total wellbeing.

Matching Summary

Match Score: 85

ImmunityBio, Inc. is seeking a Senior Specialist in Regulatory Affairs to ensure compliance with regulatory requirements in the development of their biotechnology products. The ideal candidate will have extensive experience in regulatory compliance, particularly in the pharmaceutical sector, and will contribute to the development of regulatory strategies.

Salary

Base: $135,000 to $150,000 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, Disability, FSAs, 401(k) with Match, 529 Plan, 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

  • Regulatory compliance strategies
  • Health Authority requirements
  • Common Technical Documents (CTD)
  • US and International Health Authority regulations
  • FDA, ICH guidance documents

Nice-to-have

  • Harnessing immune system power
  • Next-generation therapies and vaccines
  • Collaborative team environment
  • Professional development opportunities

Key Requirements

  • Bachelor's Degree in life sciences with 7+ years of experience
  • Master's Degree in life sciences with 5+ years of experience
  • Experience with US and International Health Authority regulatory submissions
  • Knowledge and experience with organizing responses to Regulatory Authority requests

Work Rights

Not specified

Tailored Resume

Cover Letter