Regulatory Affairs Associate

Karwell Technologies
  • North Chicago, IL
  • Instant Apply
30+ days ago

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.

Numbers & Facts

LocationNorth Chicago, IL

Skills

  • Biologyunmatched
  • Communication Skillsunmatched
  • Cross-Functionalunmatched
  • Data Managementunmatched
  • Data Qualityunmatched
  • Detail Orientedunmatched
  • Environmental Sciencesunmatched
  • Health Scienceunmatched
  • Pharmacyunmatched
  • Presentation/Verbal Skillsunmatched
  • Process Improvementunmatched
  • Quality Controlunmatched
  • Record Keepingunmatched
  • Regulationsunmatched
  • Regulatory Submissionsunmatched
  • Systems Administration/Managementunmatched
  • Writing Skillsunmatched

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