Regional Submission Publishing Senior Specialist

About the role

The Senior Specialist, Regional Submission Publishing is an individual contributor in the Regional Regulatory Operations – Asia Pacific team. The role ensures timely, accurate, and agency‑compliant preparation, publishing, transmission, and archiving of regulatory dossiers across the APAC region.

Key responsibilities

• Execute day‑to‑day publishing activities for priority and lifecycle submissions, delivering high‑quality, agency‑compliant dossiers.
• Maintain and improve publishing workflows, templates, job aids and checklists within regional and global frameworks.
• Provide hands‑on technical support and training on dossier structures, electronic submission requirements and publishing tools.
• Support system changes, testing, validation and adoption of publishing platforms such as GRACS RIIM.
• Maintain accurate operational records and status updates to facilitate issue escalation and continuous improvement.

Required profile

• Bachelor’s degree in a science, information technology or pharmacy discipline.
• Minimum 3 years of experience in Regulatory Affairs, Regulatory Operations or Submission Publishing within APAC.
• Strong attention to detail, ability to manage multiple publishing activities concurrently and meet tight deadlines.
• Effective communication and collaboration skills for interaction with cross‑functional stakeholders.

Required skills

• Experience with Liquent Insight Publisher or Lorenz DocuBridge publishing systems.
• Familiarity with Regulatory Innovation and Information Management (RIIM) platforms, such as GRACS RIIM.
• Knowledge of electronic regulatory dossier structures, formats and agency transmission methods.