Backup Coordinator / Senior Regulatory Affairs Specialist

Excelya>Full-time>Backup Coordinator / Senior Regulatory Affairs Specialist

Job description

Founded in 2014, Excelya is a ‘people-centred’ contract research organisation (CRO).

We offer a personal and authentic experience within an ambitious young healthcare company on its way to becoming the leader in clinical research in Europe with our 800 Excelyates. Our unique one-stop service provider model – which is supported by a fully-fledged functional and consultancy service provider – enables our Excelyates to work across a wide range of projects. Working with leading experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.

For our team members, excelling with care means enjoying a challenging professional environment that encourages personal, intellectual and operational participation so that together we can be the best in our field. We are committed to empowering each Excelyate to express their natural talents, develop their full potential and invest in our unique project.

 

FSP Activities : Clinical trial : phase I to III.

– Prepare the European cores documents package for international diffusion and  French submission to the competent authority  

– Coordinate operational activities and Quality Check of all deliveries

– Regulatory  team training

– Support the manager of the platform

Profile :

  • Minimum 3 years’ experience in this area

  • Master’s degree OR PharmD

  • A deep understanding of the European regulatory environment for clinical trial  

  • Project management experience and experience successfully building relationships across a diverse stakeholder team

  • Good level of English, Effective oral and written communication skills

  • Ability to work on own initiative

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