Regulatory Affairs Manager, Research Incubation Unit
University of Chicago
Chicago, IL, US
Base: $65,000.00 - $90,000.00; bonus/equity: not s...
Interpretation of fda ema ich gcp regulations
Management of irb and fda submissions
Coordination of internal audits and inspections
The role is responsible for ensuring that clinical research activities comply with relevant regulatory requirements, guidelines, and standards across the Biological Sciences Division
Job Summary
The role is responsible for ensuring that clinical research activities comply with relevant regulatory requirements, guidelines, and standards across the Biological Sciences Division.
The position involves developing, reviewing, and submitting regulatory applications such as IRB and FDA submissions while liaising with regulatory agencies and ethics committees.
The University of Chicago offers a wide range of benefits programs including health, retirement, and paid time off for eligible employees.
Matching Summary
The role is responsible for ensuring that clinical research activities comply with relevant regulatory requirements, guidelines, and standards across the Biological Sciences Division.
Salary
Base: $65,000.00 - $90,000.00; Bonus/Equity: Not specified; Benefits: Health, retirement, and paid time off included
Skills & Requirements
Must-have
Interpretation of FDA EMA ICH GCP regulations
Management of IRB and FDA submissions
Coordination of internal audits and inspections
Maintenance of regulatory compliance documentation
Training staff on regulatory requirements
Nice-to-have
Experience with electronic regulatory submission platforms
Certification in Regulatory Affairs (RAPS or CRA)
Knowledge of local and central IRB interactions
Key Requirements
College or university degree in related field
2-5 years of work experience in related job discipline