Regulatory Publisher

Overview

Position summary:

• Responsible for document formatting, publishing, and regulatory submissions.

• Manage eCTD submissions, perform quality checks, and troubleshoot errors.

• Coordinate timely submission of regulatory dossiers (NDAs, BLAs).

This job comprises of responsibilities related to document formatting, publishing, and regulatory submissions in a compliance-focused environment. It involves ensuring documents adhere to specific formatting standards, assembling submission-ready files, and managing eCTD submissions by preparing, validating, and publishing them. The role includes coordinating the timely submission of regulatory dossiers (NDAs, BLAs, etc.), performing quality checks, troubleshooting errors, and maintaining compliance with global and regional requirements. It also involves collaborating with cross-functional teams, managing software and databases, and archiving regulatory documents for future reference.