Job Details

  • Title: Regulatory Affairs Associate
  • Code: RCI-ABV-05740/05741/05742
  • Location: Abbott Park Illinois (IL) 60064
  • Posted Date: 07/11/2019
  • Duration: 4 Months
  • Status: Open
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  Job Description

Minimum Associate's Degree required

2+ years in a related area including manufacturing, regulatory affairs, R&D, or quality in the pharmaceutical, medical device, or other healthcare industry.

Description:
  • Participates and contributes in group, department and cross-functional meetings
  • Executes established business processes and may assist in development and implementation of process /system changes and/or data remediation projects
  • The Regulatory Affairs Associate I assess incoming global regulatory information and enters data into systems
  • Interacts with all areas of regulatory affairs and affiliates to ensure information is current, accurate and available in regulatory systems
  • Troubleshoots errors and system performance and issues. Works with supervisor and IT on business problem resolution and enhancements
  • Provides input on training materials and may assist in training junior team member
  • The contractor will work in two main systems, Edocs (document repository) and Tracts (internal system for internal employees to review such documents).
  • Manger isn’t looking for someone that comes from a lab, wants someone the can processing documents, especially regulatory submission processing .
  • 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 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.
  • 3 people on the team in an office setting. 
  • Local Candidates only
Experience
  • Demonstrated analytical and communication skills. 
  • 3+ years in a related area including manufacturing, regulatory affairs, R&D, or quality in the pharmaceutical, medical device, or other healthcare industry. 
  • Bachelor's degree in science related field 
  • Experience/understanding/use of software tools. 
  • 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