Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Base: $83,200.00-$137,280.00; bonus/equity: not sp...
Maintain comprehensive knowledge of regulatory standards
Review and evaluate fda submissions for drugs
Collaborate with principal investigators on study development
The position serves as an essential resource providing technical expertise and regulatory guidance for the research community at Ann & Robert H. Lurie Children's Hospital
Job Summary
The position serves as an essential resource providing technical expertise and regulatory guidance for the research community at Ann & Robert H. Lurie Children's Hospital.
Responsibilities include reviewing, evaluating, and advising on submissions for investigational new drug/device applications while ensuring compliance with FDA, IRB, and IBC standards.
The hospital offers a comprehensive rewards package including medical, dental, vision insurance, paid time off, and a 403(b) with a 5% employer match.
Matching Summary
The position serves as an essential resource providing technical expertise and regulatory guidance for the research community at Ann & Robert H. Lurie Children's Hospital.
Salary
Base: $83,200.00-$137,280.00; Bonus/Equity: Not specified; Benefits: Comprehensive package including health insurance, PTO, and 403(b) match
Skills & Requirements
Must-have
Maintain comprehensive knowledge of regulatory standards
Review and evaluate FDA submissions for drugs
Collaborate with principal investigators on study development
Ensure compliance with IRB and IBC regulations
Develop and maintain regulatory trackers and databases
Nice-to-have
Strong organizational and project management skills
Excellent communication and presentation abilities
Ability to identify process improvement opportunities
Experience in commercialization and manufacturing considerations
Commitment to fostering a diverse workplace culture
Key Requirements
Bachelor's degree in related field required
Master's or PhD preferred in Biology, Chemistry, or Life Sciences
Minimum 5 years substantive experience in regulated field
At least two years of experience in regulatory affairs
Familiarity with FDA submission processes and requirements