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Regulatory Affairs Associate

Karwell Technologies

North Chicago, IL

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JOB DETAILS
SKILLS
Biology, Communication Skills, Cross-Functional, Data Management, Data Quality, Detail Oriented, Environmental Sciences, Health Science, Pharmacy, Presentation/Verbal Skills, Process Improvement, Quality Control, Record Keeping, Regulations, Regulatory Submissions, Systems Administration/Management, Writing Skills
LOCATION
North Chicago, IL
POSTED
4 days ago
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.

About the Company

K

Karwell Technologies

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