Regulatory Affairs Associate I_

Regulatory Affairs Associate I (Contract) – Hybrid | Lake County, IL

Are you looking to launch or grow your career in Regulatory Affairs with a global pharmaceutical organization? We are seeking a Regulatory Affairs Associate I to support regulatory information management activities, regulatory submissions tracking, compliance documentation, and data integrity initiatives across global regulatory systems.

This is an excellent opportunity for recent graduates with a pharmacy or life sciences background who are interested in developing expertise in regulatory operations, submission management, and pharmaceutical product lifecycle management.

As a Regulatory Affairs Associate I, you will support regulatory information management processes and help ensure the accuracy, completeness, and compliance of regulatory data across multiple systems.

• Support regulatory information management activities utilizing key systems including COSMOS, HUBBLE, and CIU
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• Collaborate with central data management teams to ensure adherence to established data standards.
• Create and maintain market‑specific Regulatory Information Management (RIM) objects.
• Update product registrations to reflect approvals, renewals, new indications, packaging changes, and validity date extensions.
• Record and maintain regulatory commitments and obligations.

• Support tracking of regulatory submissions and correspondence activities across multiple regions.
• Ensure submission and approval dates are accurately recorded in COSMOS.
• Monitor submission archiving activities through CIU.
• Update activity statuses and maintain accurate lifecycle records.
• Verify regulatory correspondence and approval documentation are properly linked and documented.

• Partner with regional and global stakeholders to maintain data consistency and integrity.
• Support monthly quality control reporting activities and assist with data remediation efforts.
• Participate in audit and inspection support activities related to submissions, approvals, commitments, and correspondence records.
• Assist in developing regional KPI and analytics requirements within HUBBLE.
• Support adoption of system enhancements, upgrades, and process improvements.

• Work closely with regulatory teams, data management teams, analytics groups, and regional stakeholders.
• Help bridge local regulatory processes with global regulatory information management frameworks.
• Support data migration, harmonization, and continuous improvement initiatives.

• Bachelor's Degree in:
• Pharmacy
• Biology
• Pharmacology
• Medical Technology
• Other related Life Sciences disciplines

• Recent graduate or early‑career professional with a pharmacy or health sciences background.
• Strong interest in Regulatory Affairs, Regulatory Operations, or Regulatory Information Management.

• Excellent verbal and written communication skills.
• Strong attention to detail and organizational abilities.
• Ability to manage multiple priorities and meet deadlines.
• Strong analytical and problem‑solving skills.
  
  Ability to work effectively in a collaborative, cross‑functional environment.
• Proficiency with Microsoft Office applications.

• Internship, co‑op, or academic experience in pharmaceutical, biotech, healthcare, or regulatory environments.
• Exposure to regulatory processes, compliance documentation, or pharmaceutical product registrations.
• Experience working with databases or information management systems is a plus.

This opportunity provides valuable exposure to:

• Global Regulatory Affairs operations
• Regulatory Information Management (RIM) systems
• Pharmaceutical product registration processes
• Regulatory compliance and data governance
• Cross‑functional collaboration with global teams

If you're a motivated life sciences professional looking to begin a career in Regulatory Affairs with a leading pharmaceutical organization, we'd love to hear from you.