Regulatory Affairs Operation Specialist (limited) – Geneva

• Collect documents for submissions, ensuring compliance and, formatting
  
• Compile, publish and dispatch electronic and paper submissions to meet health authority requirements
  
• Interact with internal departments to ensure timely submissions and to support global filings
  
• Achieve business objectives and priorities within Regulatory Operations with a specific focus on electronic document management, electronic regulatory submissions, submission tracking and other electronic systems used by GRA
  
• Maintain and coordinate updates and problem solving issues related to publishing software
  
• Organize access to electronic Gateways to enable submissions being uploaded to Health Authorities
  
• Work closely within a team in a globally focused environment to achieve team and company goals
  
• Manage the regulatory documentation in accordance with regulations, in-house SOPs, workflows and systems.
  
• Contribute to the continuous improvement of workflows and systems.

• At least 3 years' experience in the preparation of electronic Regulatory submissions in the pharmaceutical industry.
  
• Knowledge of eCTD publishing systems (docuBridge experience an advantage), electronic document management systems and Regulatory tracking software
  
• Experience of planning and compiling submissions for CH, EU, US and ROW
  
• Fluent in French and in English

Brice Muller
Talent Acquisition Consultant
+41 58 851 81 24