Regulatory Affairs Associate I - Regulatory Information Management (RIM/COSMOS Data Management)

Regulatory Affairs Associate I - Regulatory Information Management (RIM/COSMOS Data Management)
Location: Hybrid – North Chicago, IL (onsite Tuesday, Wednesday, and Thursday)
Length of Assignment: TBD
Pay Rate: $27-30/hr (depending on candidate medical benefits preference)

Job Description:
The Regulatory Information Management Contractor will support the maintenance, accuracy, and completeness of regulatory data within COSMOS, our Regulatory Information Management solution. The position will assist with regulatory data management, inspection and audit requests, system enhancements, data remediation, and data migration and harmonization activities.

Key Responsibilities:

• Monitor activity in COSMOS for assigned products and regulatory activities, ensuring the completeness and accuracy of data.
• Follow established data standards when creating and maintaining Regulatory Information Management objects.
• Create or update product, application, and registration data, including:
  • New registrations
  • Validity-date periods
  • New indications
  • New packaging configurations
• Record and update regulatory commitments and obligations.
• Verify that submissions have been archived through CIU.
• Move notification-only activities to completed status when appropriate.
• Confirm that agency correspondence and responses are imported into COSMOS and associated with the relevant regulatory activity.
• Ensure response structures are linked to the appropriate activity.
• Confirm that approval letters are imported and associated with the applicable activity.
• Update activity dates and statuses to accurately reflect regulatory approvals.
• Support audit and inspection requests involving COSMOS data.
• Support system enhancements and regulatory data-remediation activities.
• Assist with data migration and harmonization during system upgrades, process improvements, and company acquisitions.

Qualifications:

• Bachelor’s degree in a related life-sciences discipline, such as pharmacy, biology, chemistry, medical technology, or pharmacology.
• Zero to two years of experience in the pharmaceutical, medical-device, healthcare, or a related industry.
• Zero to two years of experience in Regulatory Affairs or Regulatory Operations is preferred.
• Strong written and verbal communication skills.
• Strong attention to detail and ability to maintain complete and accurate regulatory data.
• Ability to follow established data standards and business processes.

People are our business worldwide
 
Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.