We are a national staffing firm and are currently seeking a Regulatory Data Coordinator for a prominent client of ours. This position is located North Chicago, IL 60044. Details of the position are as follows:
Job Details:
- Pay: $36 - $39/hr to Start!!
- Through end of year, with possible extension or conversion based on performance and budget.
- Onsite Monday–Thursday; remote Friday
- Position will review 900+ Requests for Information (RFIs) received from the FDA, Health Canada, EMEA, and other global and regional health authorities.
- Position will interpret regulatory questions, categorize each request using predefined technical and product criteria, and identify information requiring clarification.
- Position will compile and organize regulatory information in standardized Excel tracking datasets while maintaining accuracy and data integrity.
- Position will identify recurring themes, calculate summary metrics, and prepare trend analysis for leadership reporting and future comparisons.
Qualifications:
- A bachelor’s or master’s degree is Required!
- A professional or academic background in regulatory affairs is Required!
- Experience working with FDA, Health Canada, and EMEA regulations is Required!
- Experience reviewing and categorizing regulatory information or Requests for Information (RFIs) is Preferred!
- Experience with Excel, including data entry, lookups/VLOOKUP functions, filtering, data slicing, and filing is Preferred!
- Pharmaceutical regulatory affairs or regulatory operations experience, including experience with clinical submissions is Preferred!
If you are interested in hearing more about the position, please respond to this post with your resume attached or contact me at (813) 356-0550.
Please forward this email to any friends or colleagues as we do offer a Referral Bonus for any candidate who is hired and still gainfully employed after 30 days.
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