Regulatory Compliance Specialist

North Chicago, IL 60064

Post Date: 02/12/2018 Job ID: 25831 Category: Pharmacy

Job Description:
  • Work with US, ex-US & CMC areas to establish data categorization and provide analysis of data in system.
  • Responsible for reviewing & maintaining registration compliance information in accordance with change control processes.
  • Receive and enter registration compliance data into system.
  • Responsible for maintaining keyword lists associated with the data entry requirements.
  • Work with global regulatory affairs area representatives & affiliates to build relationship and common understanding of the requirements for Registration Compliance.
  • Assimilate disparate information from multiple resources, analyze for trends, adjust and raw inferences.
  • Track metrics associates with data capture/entry effort.
  •   Execute business processes for Registration Compliance.
  • Review data & determine if new categories/classifications are required.

Qualifications:
  • 3+ years in a related area including manufacturing, regulatory affairs, quality in the pharmaceutical, medical device, or other healthcare industry.
  • Experience/understanding/use of software tools.
  • Demonstrated analytical capabilities.

For more information, please contact A-Line Staffing at 877-782-3334.

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