Regulatory Affairs Associate

Karwell Technologies

  • North Chicago, IL
  • 30+ days ago

    Highlights

    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. Partner with global and regional teams to ensure regulatory submissions and correspondence are accurately documented and aligned across markets.

    Numbers & Facts

    LocationNorth Chicago, IL

    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.