Regulatory Information Management Associate

Target PR Range: $20–30/hr depending on experience.

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  • Monitor that submission has been archived via CIU.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

• 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.