Regulatory Affairs Associate I

Role Overview

This contract opportunity is for a Regulatory Affairs Associate I based in North Chicago, Illinois, with a hybrid schedule that requires onsite presence on Tuesday, Wednesday, and Thursday. The role is focused on regulatory information management, submission tracking, and maintaining accurate records across regional systems and processes.

The compensation for this position is $30 to $33 per hour.

Required Background

Applicants should have a bachelor’s degree in Regulatory Affairs. The ideal candidate will bring experience handling regulatory data, familiarity with Veeva, and a background in pharmacy or health sciences, including fresh graduates from those fields. Strong verbal and written communication skills are also important.

Key Duties

The associate will help manage planned submissions and approvals across the region, support regulatory information management work, and maintain key systems and processes such as COSMOS, HUBBLE, and CIU. The role also involves coordinating with the central data management team to build market-specific RIM objects following agreed data standards.

Additional work includes updating product registrations to reflect approvals or renewals, recording obligations and commitments, and connecting local regulatory workflows with the COSMOS activity framework to ensure complete and accurate tracking of submissions and correspondence across countries and regions. The position requires active monitoring of submission and approval dates, follow-up with affiliates when needed, and confirmation that submissions are properly archived in CIU.

The associate will also ensure notification-only activities are closed correctly, verify that agency correspondence and responses are imported into COSMOS, confirm response structures are tied to the correct activity, and make sure approval letters and related status updates are captured accurately. Support for audit and inspection requests, monthly quality-control reporting, gap identification, and data remediation is also expected. The role further includes helping define KPI and metrics needs, supporting analytics development in HUBBLE, and assisting with system enhancements, migrations, data harmonization, and process improvement initiatives.

Additional Information

This position is hybrid in North Chicago, Illinois, and follows an onsite schedule on Tuesdays, Wednesdays, and Thursdays.

Compensation

Pay is set at $30 to $33 per hour.

Eligibility

Fresh graduates with a pharmacy or health sciences background are encouraged to apply, provided they meet the education and communication requirements and have relevant regulatory data exposure.

Tools and Systems

Work will center around COSMOS, HUBBLE, CIU, and Veeva.

Working Style

The role calls for close coordination with regional and central teams, attention to detail, and consistent follow-through on regulatory recordkeeping and data quality tasks.

• Support regional regulatory information management activities across core systems and workflows.
• Work with the central data management team to create market-specific RIM objects in line with established data standards.
• Update product registrations to reflect approvals, renewals, new validity periods, new indications, or new pack details.
• Record and maintain commitments and obligations accurately.
• Link local regulatory processes with the COSMOS framework to ensure complete tracking of submissions and correspondence.
• Coordinate with other regional data leads to keep records aligned across countries and regions for reporting purposes.
• Track submission and approval dates in COSMOS and follow up with affiliates when distributor submission dates need confirmation.
• Verify that submissions are archived through CIU.
• Close out notification-only activities by moving them to completed status.
• Ensure agency correspondence and responses are imported into COSMOS against the correct activity.
• Confirm that response structures are tied to the appropriate regulatory activity.
• Import approval letters, update activity status, and record approval dates correctly.
• Assist with audit and inspection requests related to submissions, commitments, correspondence, and approval data.
• Partner with the central team on monthly QC reporting, gap analysis, and remediation activities.
• Help define KPI and metrics needs for regional reporting.
• Work with regional data leads and the analytics team to improve advanced analytics capabilities in HUBBLE.
• Support adoption of system enhancements and new functionality.
• Assist with data migration, harmonization, and process-improvement work during upgrades.

• Bachelor’s degree in Regulatory Affairs.
• Experience working with regulatory data.
• Prior exposure to Veeva.
• Fresh graduate with a pharmacy or health sciences background may qualify.
• Strong verbal and written communication skills.

• Hybrid work arrangement with three onsite days each week.
• Hourly pay in the $30 to $33 range.
• Opportunity to work with regulatory systems and regional data operations.

• Candidates with a bachelor’s degree in Regulatory Affairs.
• Fresh graduates from pharmacy or health sciences backgrounds.
• Applicants with regulatory data experience and Veeva exposure.
• Professionals who can communicate clearly in both spoken and written English.

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