Publishing Officer

• Perform regulatory publishing activities in eCTD, NeeS, ePaper, and ACTD formats
• Support submissions across EU, US, Canada, Australia, GCC, ASEAN, and other global regions
• Compile, publish, and validate regulatory submissions in line with health authority requirements
• Ensure accuracy, consistency, and technical compliance of published submissions
• Coordinate and plan assigned publishing projects in collaboration with internal stakeholders
• Perform quality checks and address validation findings prior to submission
• Maintain submission documentation and ensure proper version control
• Work effectively within defined timelines while managing multiple submissions

• Bachelor’s degree in Life Sciences or a related discipline
• 3+ years of experience in Regulatory Affairs / Regulatory Operations with hands-on eCTD publishing exposure
• Experience working on international, EU, and RoW submissions
• Experience with eCTD and NeeS publishing
• Strong knowledge of electronic document management systems (eDMS)
• PDF preparation and editing using Adobe Acrobat Pro
• Familiarity with ISI Toolbox / Evermap (bookmarks, hyperlinks, TOC creation)
• Basic understanding of Regulatory Affairs processes and submission lifecycle
• Highly organized and methodical approach to work
• Strong attention to detail and quality mindset
• Ability to manage priorities and work under tight timelines
• Adaptable and comfortable working in a global, remote environment
• Clear communication and collaboration skills

Hands-on experience with DocuBridge