Regulatory Affairs Associate I

Description:

Regulatory Information Management Contractor

Location: Onsite Hybrid (Tues, Wed, Thurs) North Chicago

Responsibilities May Include:

• 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  • Monitor that submission has been archived via CIU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

Provide the days of the week and the hours that this position will require:

Additional Details

• Manager's Requested NA : (No Value)
• Does the position allow for the worker to be virtual/remote? : No
• Shore Options Available for this Position : Onshore Only
• Provide the days of the week and the hours that this position will require: : (No Value)