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Regulatory Affairs Associate

Job in Great Lakes, Lake County, Illinois, 60088, USA
Listing for: Katalyst Healthcares & Life Sciences
Full Time position
Listed on 2026-08-05
Job specializations:
  • Pharmaceutical
    Regulatory Compliance Specialist, Healthcare Compliance
Job Description & How to Apply Below
Location: Great Lakes

Job Title

Job Description

Responsibilities

Support regional Regulatory Information Management (RIM) activities using systems such as COSMOS, HUBBLE, and CIU.

Create and maintain regulatory records, including:

  • Product registrations
  • Approval and renewal updates
  • Indication and packaging changes
  • Commitment and obligation tracking
  • Partner with global and regional teams to ensure regulatory submissions and correspondence are accurately documented and aligned across markets.
  • Monitor submission and approval activities to maintain data integrity and compliance.
  • Support audit and inspection requests related to regulatory submissions and approvals.
  • Participate in monthly quality control reviews, identify data gaps, and support remediation efforts.
  • Assist with system enhancements, upgrades, and continuous process improvement initiatives.
Requirements

Bachelor's degree in Regulatory Affairs, Pharmacy, Health Sciences, or a related discipline.

Experience or exposure to Regulatory Data Management.

Familiarity with Veeva systems.

Strong written and verbal communication skills.

High attention to detail and an interest in global regulatory processes.

Why This Opportunity Stands Out

Whether you're a recent graduate or early in your Regulatory Affairs career, this role provides valuable exposure to regulatory operations, global submissions, data governance, and cross-functional collaboration within a highly respected life sciences environment.

Interested or know someone who would be a great fit? Reach out today.

Position Requirements
10+ Years work experience
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