Job Details

  • Title: Regulatory Affairs Associate
  • Code: RCI-6792/6793/6795/6796
  • Location: North Chicago Illinois (IL) 60064
  • Posted Date: 11/06/2019
  • Duration: 12 Months
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  Job Description

Local Candidates only

Job Description:

  • The Regulatory Information Data Coordinator assesses incoming global regulatory information for entry into client`s Registration and Documentation Management systems.
  • They interact with all areas of regulatory affairs and affiliates to ensure registration management information is current, accurate, and available in regulatory systems.
  • They execute established business processes and may assist in development and implementation of process/system changes and/or data remediation projects.
  • They troubleshoot errors and system performance issues and work with their supervisor and IT on business problem resolution and enhancements.
  • They participate and contribute in group, department and cross-functional meetings and may assist in training junior team members.

Experience:

  • Associate's Degree
  • 2+ years in a related area including manufacturing, regulatory affairs, R&D, or quality in the pharmaceutical, medical device, or other healthcare industry.
  • Experience/understanding/use of software tools.
  • Demonstrated analytical and communication skills.
  • Skills and knowledge of drug submissions

Intake Notes:

Top skills/experience the manager is looking for

  1. Any kind of regulatory experience
  2. Documentation processing
  3. Analytical skills, make sure the information is clean and accurate
  4. Computer savvy – this group spends all their time processing regulatory submissions and is in front of a PC all day working in several programs
  • Manger isn’t looking for someone that comes from a lab, wants someone they can processing documents, especially regulatory submission processing.
  • The contractor will work in two main systems, Edocs (document repository) and Tracts (internal system for internal employees to review such documents).
  • The contractor should be analytical and very attentive to detail to catch errors and/or locate data within documents.
  • Submittals come into the team from client`s Affiliates and involve sending them to outside regulatory bodies.
  • Role is typically 8-5pm Mon-Fri with some flex to come in earlier or later.
  • One day work from home is possible depending on performance as it is a privilege.