New
Regulatory Information Management Contractor
Spectraforce Technologies | |
United States, Illinois, North Chicago | |
Aug 28, 2026 | |
|
Position Title: Regulatory Information Management Contractor
Work Location: North Chicago, IL 60064 Assignment Duration: 06 Months (possible extension) Work Arrangement: Onsite - Hybrid (Tues, Wed, Thurs) Position Summary: Monitors activity in COSMOS (Regulatory Information Management solution) for assigned products and activities, including ensuring completeness and accuracy of data Key Responsibilities: * Monitors activity in COSMOS (Regulatory Information Management solution) for assigned products and activities, including ensuring completeness and accuracy of data * Follows agreed upon data standards for creating RIM objects, including but not limited to: * Create or update product, application, and registration data (e.g. new registration, new validity date period, new indication, new pack) * Commitment/Obligation recording and updating * Monitor that submission has been archived via CIU * Move activity to a completed status if a notification only activity * Monitor that Correspondence/responses from agency are imported into Cosmos in association with relevant activity * Response structures linked to relevant activity * Approval letter imported in relation to relevant activity; Activity status and date updated to reflect approval * Support Audit/Inspection requests related to data in Cosmos * Support system enhancements and data remediation activities * Support migration and harmonization of data during system upgrades, process improvements, and acquisitions Qualifications & Experience: * Required Education: Bachelor's degree in related life sciences (pharmacy, biology, chemistry, medical technology pharmacology) * Required Experience: 0-2 years in pharmaceutical, medical device or healthcare related field * Preferred Experience: 0-2 years in Regulatory Affairs or Regulatory Operations role * Good communication, both oral and written | |
Aug 28, 2026