Regulatory Publishing Officer

The Publishing Officer will support regulatory submission publishing activities for global markets as part of the Publishing project. The role focuses on the preparation, compilation, and publishing of regulatory submissions in multiple electronic formats, ensuring compliance with regional regulatory authority requirements and internal quality standards.

Key Responsibilities

• 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.

Required Qualifications

• Bachelors 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.

Technical Skills

Mandatory:

• Experience with eCTD and NeeS publishing.
• Strong knowledge of electronic document management systems (eDMS).
• PDF preparation and editing using Adobe Acrobat Pro.

Desirable:

• Hands-on experience with DocuBridge (Preferred
• Familiarity with ISI Toolbox / Evermap (bookmarks, hyperlinks, TOC creation).
• Basic understanding of Regulatory Affairs processes and submission lifecycle.

Soft Skills & Competencies

• 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.