Regulatory Operations Associate - RIM & Data Systems

Job Summary

Responsibilities

• Monitor activity in COSMOS (RIM solution) for assigned products, ensuring data completeness, compliance, and accuracy.
• Create and update product, application, and registration data following strict organizational data standards.
• Track regulatory commitments and ensure submission archiving, correspondence, agency responses, and approval letters are linked correctly.
• Update activity statuses and key dates to reflect regulatory approvals and notifications.
• Support audit and inspection requests, system enhancements, data remediation, and data migration projects during system upgrades or acquisitions.

Qualifications

• Required: Bachelor's degree in a related life science (e.g., Pharmacy, Biology, Chemistry, Medical Technology, Pharmacology).
• 0-2 years of experience in the pharmaceutical, medical device, or healthcare-related field.
• Strong written and oral communication skills.

Preferred

• 0-2 years of hands-on experience in a Regulatory Affairs or Regulatory Operations role.

Skills

• Regulatory Affairs Operations
• Regulatory Information Management (RIM)

Benefits

Comprehensive benefits package including:

• Medical
• Prescription
• Dental
• Vision
• AD&D
• Life insurance
• Short-term disability
• A 401K plan

Pay

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Schedule

This is a 1-year hybrid contract position.

Location

North Chicago, Illinois