Regulatory Submissions Publishing Lead (eCTD)

Artech is seeking a Regulatory Affairs Operations submissions specialist to publish, submit and maintain regulatory filings in coordination with Global Regulatory Leads. You will ensure compliance with ICH/FDA regulations, manage submission workflows, and dispatch through the FDA Gateway in a fast-paced, highly regulated environment.

The role requires experience in publishing capabilities across eCTD backbone and related modules, with a focus on quality and timely delivery of submissions to