Publishing Officer / Specialist – Regulatory Submissions

About the role

The Publishing Officer / Specialist will support regulatory submission publishing activities for global markets. 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 and plan publishing projects with internal stakeholders.
• Conduct quality checks and address validation findings before submission.
• Maintain submission documentation and version control.
• Manage multiple submissions within defined timelines.

Required profile

• Bachelor’s degree in Life Sciences or a related discipline.
• 5+ years of experience in Regulatory Affairs or Regulatory Operations with hands‑on eCTD publishing exposure.
• Experience with international, EU, and RoW submissions.
• Strong attention to detail and ability to work under tight timelines.
• Clear communication and collaboration skills in a global, remote environment.

Required skills

• eCTD publishing
• NeeS publishing
• ePaper and ACTD formats
• Electronic Document Management Systems (eDMS)
• Adobe Acrobat Pro for PDF preparation and editing
• DocuBridge (preferred)
• ISI Toolbox / Evermap for bookmarks, hyperlinks, and TOC creation