[Remote] Regulatory Operations - eCTD Publishing Head

• Collaborate closely with submission managers to lead the preparation of high-quality regulatory submission packages (eCTD, NeeS, or paper), ensuring all documents meet internal standards and regulatory guidelines.
  
• Guarantee that submission packages meet the necessary technical standards for validation by health authorities.
  
• Take a leadership role in training and mentoring both internal teams and external publishing partners.
  
• Support submission teams in defining content requirements and aligning timelines to ensure accurate and timely submissions.
  
• Proactively identify and resolve or escalate any risks or issues that may hinder successful submission completion.
  
• Monitor project progress, daily publishing tasks, and address any irregularities, contributing to departmental metrics tracking.
  
• Provide general administrative support as needed.
  
• Lead the creation and maintenance of publishing procedures and documentation, including user acceptance testing for new or updated tools, and delegate tasks as appropriate.
  
• Serve as a subject matter expert for specific processes or functions, offering guidance and support to team members and external partners.
  
• Analyze workflows and business practices, identify opportunities for improvement, and drive implementation of enhanced processes.
  

Requirements

• At least 4 years of hands-on experience in regulatory publishing.
  
• Proficient in Lorenz docuBridge, Liquent InSight Publisher, and global publishing systems is a Plus
  
• Skilled in using electronic document management systems commonly used in the industry.
  
• Demonstrated experience in project leadership and team coordination.
  
• Fluency in both English and Japanese is required.