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 up-to-date regulatory knowledge
The Office of Clinical Research provides expertise, resources, and infrastructure to facilitate clinical research operations while promoting compliance and human subject protection

Job Summary

  • The Office of Clinical Research provides expertise, resources, and infrastructure to facilitate clinical research operations while promoting compliance and human subject protection.
  • The Regulatory Affairs Manager is responsible for ensuring that clinical research activities comply with relevant regulatory requirements, guidelines, and standards across the Biological Sciences Division.
  • 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, resources, 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 available

Skills & Requirements

Must-have

  • Develop and submit regulatory applications
  • Interpret FDA EMA ICH GCP regulations
  • Maintain up-to-date regulatory knowledge
  • Liaise with regulatory agencies and ethics committees
  • Oversee maintenance of regulatory files
  • Provide regulatory guidance during study phases

Nice-to-have

  • Experience interacting with local and central IRBs
  • Familiarity with electronic regulatory submission platforms
  • Certification in Regulatory Affairs (RAPS CRA)
  • Ability to coordinate compliance committee meetings
  • Strong communication skills for stakeholder updates

Key Requirements

  • College or university degree in related field
  • 2-5 years of work experience in related discipline
  • Knowledge of FDA, EMA, ICH, and GCP regulations

Work Rights

Not specified

Tailored Resume

Cover Letter