Regulatory Affairs Associate I
The Fountain Group · North Chicago, IL
CONTRACT
Posted Aug 24, 2026
Job Description
Onsite - Hybrid (Tues, Wed, Thurs) - North Chicago
Pay: $31-$33/hr
REQUIRED:
- Bachelor’s degree in a Life Sciences discipline, such as Pharmacy, Biology, Chemistry, Medical Technology, Pharmacology, or a related scientific field.
- 0-2 years of experience within the pharmaceutical, medical device, biotechnology, or healthcare industry.
- Experience or academic/internship exposure to Regulatory Affairs, Regulatory Operations, or regulatory documentation preferred.
- Familiarity with Regulatory Information Management (RIM) systems and/or regulatory databases; experience with COSMOS is a plus.
- Strong data entry, data management, and data quality skills with the ability to review regulatory information for completeness, accuracy, and consistency.
- Ability to create, update, and maintain product, application, registration, submission, and regulatory activity information within electronic systems.
- Understanding of or exposure to regulatory submissions, registrations, agency correspondence, commitments/obligations, approval documentation, and product lifecycle activities.
- Strong attention to detail and organizational skills, with the ability to follow established data standards, procedures, and regulatory processes.
- Proficiency with Microsoft Office, particularly Excel, Word, and Outlook, and the ability to quickly learn new regulatory systems and databases.
- Strong written and verbal communication skills with the ability to collaborate effectively with Regulatory Affairs and cross-functional teams.
Preferred: Experience with RIM systems, Veeva Vault RIM, regulatory data management, Regulatory Operations, data remediation/migration, audit/inspection support, or pharmaceutical product registrations.
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- Monitor that submission has been archived via CIU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
Pay: $31-$33/hr
REQUIRED:
- Bachelor’s degree in a Life Sciences discipline, such as Pharmacy, Biology, Chemistry, Medical Technology, Pharmacology, or a related scientific field.
- 0-2 years of experience within the pharmaceutical, medical device, biotechnology, or healthcare industry.
- Experience or academic/internship exposure to Regulatory Affairs, Regulatory Operations, or regulatory documentation preferred.
- Familiarity with Regulatory Information Management (RIM) systems and/or regulatory databases; experience with COSMOS is a plus.
- Strong data entry, data management, and data quality skills with the ability to review regulatory information for completeness, accuracy, and consistency.
- Ability to create, update, and maintain product, application, registration, submission, and regulatory activity information within electronic systems.
- Understanding of or exposure to regulatory submissions, registrations, agency correspondence, commitments/obligations, approval documentation, and product lifecycle activities.
- Strong attention to detail and organizational skills, with the ability to follow established data standards, procedures, and regulatory processes.
- Proficiency with Microsoft Office, particularly Excel, Word, and Outlook, and the ability to quickly learn new regulatory systems and databases.
- Strong written and verbal communication skills with the ability to collaborate effectively with Regulatory Affairs and cross-functional teams.
Preferred: Experience with RIM systems, Veeva Vault RIM, regulatory data management, Regulatory Operations, data remediation/migration, audit/inspection support, or pharmaceutical product registrations.
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
Additional Details
- City
- North Chicago
- State
- Illinois
- Country
- US
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