Regulatory Affairs Specialist

Lurie Children's Hospital

Streeterville, IL, United States
Base: $83,200.00-$137,280.00; bonus/equity: not sp...
Fda regulatory submissions
Irb and ibc compliance
Research community guidance
This position serves as an essential resource within the Medical Center, providing technical expertise and regulatory guidance for the research community with a focus on the development of pre-market regulatory submissions for drugs, biologics and devices

Job Summary

  • This position serves as an essential resource within the Medical Center, providing technical expertise and regulatory guidance for the research community with a focus on the development of pre-market regulatory submissions for drugs, biologics and devices.
  • The Regulatory Affairs Specialist will collaboratively liaise with several groups to facilitate regulatory and operational compliance, including the Office of Clinical and Community Trials (OCCT), principal investigators (PIs), research fellows and regulatory coordinators.
  • For full time and part time employees who work 20 or more hours per week we offer a generous benefits package that includes: Medical, dental and vision insurance, Employer paid group term life and disability, and a 403(b) with a 5% employer match.

Matching Summary

This position serves as an essential resource within the Medical Center, providing technical expertise and regulatory guidance for the research community with a focus on the development of pre-market regulatory submissions for drugs, biologics and devices.

Salary

Base: $83,200.00-$137,280.00; Bonus/Equity: Not specified; Benefits: Comprehensive rewards package

Skills & Requirements

Must-have

  • FDA regulatory submissions
  • IRB and IBC compliance
  • research community guidance
  • regulatory document compilation
  • regulatory agency communication
  • investigator-initiated research support

Nice-to-have

  • process improvement identification
  • best practices encouragement
  • collaboration with research teams
  • emerging trends awareness

Key Requirements

  • Bachelor's degree required
  • 5 years substantive experience in research
  • 2 years regulatory affairs experience
  • Familiarity with FDA submission processes
  • Certification or eligibility for certification

Work Rights

Not specified

Tailored Resume

Cover Letter