Regulatory Affairs Manager, Research Incubation Unit

University of Chicago

Chicago, IL, US
Base: $65,000.00 - $90,000.00; bonus/equity: not s...
Develop and submit regulatory applications
Interpret fda ema ich gcp regulations
Maintain regulatory files for audits
The Office of Clinical Research provides expertise and infrastructure to facilitate clinical research operations while promoting compliance and human subject protection

Job Summary

  • The Office of Clinical Research provides expertise and infrastructure to facilitate clinical research operations while promoting compliance and human subject protection.
  • This role manages regulatory submissions, oversees compliance documentation, and coordinates interactions with regulatory authorities to ensure safe and ethical conduct of trials.
  • The University of Chicago offers a wide range of benefits programs including health, retirement, and paid time off for eligible employees.

Matching Summary

The Office of Clinical Research provides expertise and infrastructure to facilitate clinical research operations while promoting compliance and human subject protection.

Salary

Base: $65,000.00 - $90,000.00; Bonus/Equity: Not specified; Benefits: Health, retirement, and paid time off included

Skills & Requirements

Must-have

  • Develop and submit regulatory applications
  • Interpret FDA EMA ICH GCP regulations
  • Maintain regulatory files for audits

Nice-to-have

  • Experience with electronic submission platforms
  • Certification in Regulatory Affairs RAPS CRA
  • Ability to train internal research staff

Key Requirements

  • College or university degree in related field
  • 2-5 years of work experience in related discipline
  • Knowledge of local and central IRBs

Work Rights

Not specified

Tailored Resume

Cover Letter