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

  • Bachelor’s degree in Life Sciences or a related discipline.

  • 5+ years of experience in Regulatory Affairs / Regulatory Operations with hands-on eCTD publishing exposure.

  • Experience working on international, EU, and RoW submissions.

Technical Skills

  • Experience with eCTD and NeeS publishing.

  • Strong knowledge of electronic document management systems (eDMS).

  • PDF preparation and editing using Adobe Acrobat Pro.

  • 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.

Publish Date

31 July, 2026

Spontaneous Application

Publishing Officer/ Specialist - VAF 600

New opportunities open up across PLG all the time. If nothing matches right now, send us a spontaneous application: we will keep you in mind for what comes next.

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