Publishing Expert – Regulatory Submissions

About the role

The Publishing Expert will support regulatory submission publishing activities for global markets, acting as part of a publishing project team. The role focuses on preparing, compiling and publishing regulatory submissions in multiple electronic formats while ensuring compliance with regional authority requirements and internal quality standards.

Key responsibilities

• Perform publishing activities in eCTD, NeeS, ePaper and ACTD formats.
• Support submissions across EU, US, Canada, Australia, GCC, ASEAN and other regions.
• Compile, publish and validate submissions in line with health authority requirements.
• Ensure accuracy, consistency and technical compliance of published submissions.
• Coordinate publishing projects with internal stakeholders and manage timelines.
• Conduct quality checks and address validation findings before submission.
• Maintain submission documentation and version control.

Required profile

• Bachelor’s degree in Life Sciences or a related discipline.
• 5+ years of experience in Regulatory Affairs/Operations with hands‑on eCTD publishing exposure.

Required skills

• eCTD, NeeS, ePaper and ACTD publishing.
• Electronic document management systems (eDMS).
• PDF preparation and editing using Adobe Acrobat Pro.
• DocuBridge (preferred) and familiarity with ISI Toolbox/Evermap for bookmarks, hyperlinks and TOC creation.