• 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 WoW , 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 CmdH 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 EtoE 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