Kelly Science & Clinical is seeking a Regulatory Affairs Operations Specialist near Bridgewater, NJ.

6 month contract position

Shift: Monday - Friday 8am-5pm

Compensation: $50-$60/hr DOE

Responsibilities:

• Responsible for publishing regulatory submissions in various formats including eCTD/NeeS, performing quality control reviews of publishing outputs, and dispatching submissions to the relevant Health Authorities including the US FDA and Health Canada.
  
• Responsible for preparing, dispatching and archiving 2253 submissions for OPDP.
  
• Communicating with RA Strategy and/or CMC Leads to ensure content accuracy and identify issues that could be incompliant with health authority guidance or impact compliance timelines.
  
• Ensuring final documents are submission-rea...