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-ready and compliant with applicable health authority requirements while addressing any advanced document or technical issues as needed.
+ Archiving regulatory s...