Senior Manager, Regulatory Publishing

Key Responsibilities

• Partner with submission managers to lead the creation of high-quality submission packages (eCTD, NeeS, Paper) using submission-ready documents that comply with both internal and external electronic submission guidelines.
  
• Ensure all submission assemblies meet the technical integrity standards required for health authority validation tools.
  
• Lead and mentor internal and external publishing staff, providing training as needed.
  
• Support submission project teams in defining content requirements and timeline milestones to deliver right-first-time submissions.
  
• Proactively identify, assess, and resolve—or escalate—risks or issues that may affect the timely and successful delivery of regulatory submissions.
  
• Track project status, daily production activities, and publishing anomalies to maintain accurate departmental metrics.
  
• Lead the development and documentation of publishing processes, including user acceptance testing for new or updated publishing tools, and delegate activities to publishing staff as appropriate.
  
• Serve as a subject matter expert for specific functions or processes, offering guidance to both internal teams and external stakeholders.
  

• Review and enhance business processes, identifying areas for improvement and driving the implementation of effective solutions.
  

Requirements

• Experience in regulatory publishing.
  
• Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Medical, or related scientific discipline.
  
• Proficiency with Lorenz docuBridge, Liquent InSight Publisher, and global publishing tools.
  
• Experience using industry-standard electronic document management systems.
  
• Proven track record in project management and team leadership.