Tech Stack

Description

You will prepare and format regulatory submission documents for global health authorities, ensuring compliance with eCTD standards. You will collaborate with cross-functional teams to manage concurrent submission activities and conduct quality control checks.

Requirements

• Bachelor's degree required
• 3+ years pharmaceutical industry experience in Regulatory Affairs, Regulatory Operations or Medical Writing
• Knowledge and experience with eCTD submissions
• Experience with enterprise document management systems, preferably Veeva RIM
• Understanding of global industry standards and validation concepts

Responsibilities

• Prepare and format submission-ready documents including PDF standards, bookmarks, hyperlinks, and accessibility elements
• Ensure documents meet technical standards (PDF/A compliance, OCR/searchability, file size limits)
• Verify tracked changes, comments, metadata are removed before pre-publishing
• Serve as subject-matter expert for Starting Point templates and provide training
• Perform technical QC checks on documents prior to publishing