Location
bengaluru, karnataka, India
Posted
July 04, 2026
Job Description
- Format regulatory documents according to company and regulatory agency standards
- Create and maintain document templates, style guides and formatting standards
- Create and maintain submission-ready PDFs including Bookmarks, Hyperlinks, Table of Contents, page numbering, metadata etc.
- Perform quality control (QC) reviews of regulatory documents before publishing and submission.
- Ensure compliance with CTD/eCTD, NeeS, and eDok formatting requirements.
- Support preparation of dossiers for submissions to agencies such as US FDA, EMA, MHRA, Swissmedic and Health Canada
- Manage document life cycle activities, version control and archival
- Coordinate with Regulatory affairs, medical writing, CMC, Clinical and Quality teams to obtain and process submission documents
- Support Publishing teams during dossier compilation and submission activities
- Maintain submission trackers, regulatory archives and document reposit...