Senior Regulatory Affairs And Research Systems Manager - Pediatrics

University of Chicago

Chicago, IL, US
Base: $110,000.00 - $160,000.00; bonus/equity: not...
7+ years regulatory affairs experience
Irb submission and approval management
Fda ind ide submissions maintenance
The Senior Regulatory Affairs and Research Systems Manager will lead the Department of Pediatrics' clinical research program by managing regulatory compliance and overseeing Clinical Trial Management System functionality

Job Summary

  • The Senior Regulatory Affairs and Research Systems Manager will lead the Department of Pediatrics' clinical research program by managing regulatory compliance and overseeing Clinical Trial Management System functionality.
  • This role serves as the primary liaison between principal investigators, FDA, IRBs, and other regulatory bodies to ensure all pediatric studies meet strict local and federal standards.
  • The University of Chicago offers a competitive salary range of $110,000 to $160,000 along with comprehensive health, retirement, and paid time off benefits.

Matching Summary

The Senior Regulatory Affairs and Research Systems Manager will lead the Department of Pediatrics' clinical research program by managing regulatory compliance and overseeing Clinical Trial Management System functionality.

Salary

Base: $110,000.00 - $160,000.00; Bonus/Equity: Not specified; Benefits: Health, retirement, and paid time off included

Skills & Requirements

Must-have

  • 7+ years regulatory affairs experience
  • IRB submission and approval management
  • FDA IND IDE submissions maintenance
  • Clinical Trial Management System oversight
  • GCP and 21 CFR compliance training

Nice-to-have

  • Experience with cooperative group studies
  • ACRP or SOCRA research certification
  • Master's degree in regulatory affairs
  • Strategic planning for research portfolios
  • Complex data entry protocol development

Key Requirements

  • Bachelor's degree in related field
  • Minimum 7 years work experience
  • Knowledge of 21 CFR regulations
  • ACRP/SOCRA certification preferred

Work Rights

Not specified

Tailored Resume

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