Regulatory Publishing Specialist (Advanced Word Formatting)

The Regulatory Publishing Specialist is responsible for the expedient and efficient preparation of client electronic submission deliverables and dossiers that meet current local, regional, and ICH regulatory and technical requirements, ensuring successful regulatory review outcomes. This role involves coordinating and managing client electronic submission deliverables, assisting in the preparation of electronic document outputs that meet regulatory publishing requirements, and ensuring all final electronic deliverables meet current regulatory electronic document requirements and guidance. The specialist will also assist in developing and implementing project-specific processes, act as a liaison for electronic submissions with sponsors, evaluate publishing needs in relation to project timelines, quality, and delivery, and engage with project team members and functional units to resolve issues and mitigate barriers to delivery. The role requires independent evaluation and delivery of publishing tasks, managing several complex projects in parallel, and adapting to changing priorities.