• Ensure Maintenance and optimization of the existing sharepoints (more than 10 Sharepoints in total to maintain)
  
• Creation of new Sharepoints when needed
  
• Prepare and Manage all training for PLM Portal (optimization of wows for the EU platform to embrace CHC needs)
  
• Weekly meetings with PXL , control/explanation/ amelioration for the Wo W , ongoing/new /upcoming varaitions
  
• Veeva reports creation /maintenance
  
• Manage Article 23 reports and set up a wow to ensure notification occurs at local level : veeva reports, table cleaning , affiliates contact
  
• Manage Cmd H notifications – Upcoming WS from the SRF extract ( to be able to communicate earlier at the beg of the LRC approval)
  
• Coordinates Renewals preparation for MRP/DCP : integrate way of working of renewals into the EU platform
  
• Manage ESPM portal at EU level
  
• Execute regulatory intelligence of EMA website/ PLM portal and attend all necessary meeting from EMA with regards to the implementation of PLM portal and shortages notification portal ESMP
  

About you

• Bachelor of Science or equivalent required in science or engineering, Master of Science preferred for this position. Pharmacy degree preferred.
  
• Minimum of 5 years in pharmaceutical industry with demonstrated experiences in European regulatory affairs.
  
• Good level of understanding of regulatory procedures as well as Eto E process
  
• Ability to think strategically and to translate business and technical objectives into roadmaps, projects and data strategies to support foundation and evolution of capabilities and platforms
  
• Collaborative approach and ability to cooperate transversally and to act for change for Regulatory
  
• Ability to lead and drive and to thrive in a fast-paced team environment
  
• Excellent interpersonal skills, negotiation skills, and verbal and written communications
  
• Must be able to quickly accommodate to changing priorities, and also to meet tight deadlines while maintaining high quality standards
  
• Proactivity, Experience in problem – solving and analysis. Ability to multi-task and to work in a global team environment, customer focused and action oriented.
  
• Understanding of organizational and inter-cultural sensitivities and able to apply this knowledge to day-to-day practices.
  
• Good networking ability
  
• Ability to resolve issues and proactivity.
  
• Fluent in spoken and written English