Regulatory Project Manager

Job description

Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.

We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.

For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.

What we offer:

Reporting to the team leader of the Registration Department, You will be responsible for all actions relating to obtaining, monitoring and maintaining marketing authorizations in France and Europe:

  • Filing and follow-up of MA applications at national and European level
  • Drafting, filing and follow-up of the evaluation with the competent Authorities of the files for pharmaceutical variations, MA renewals, Requests for Information Changes (RICs) and regulatory variations until their practical implementation
  • Follow-up of the registration 
  • Interface with the various internal departments, experts, active ingredient manufacturers and manufacturers.
  • You will be responsible for the regulatory design, updating and validation of printed packaging articles
  • Review and implementation of Risk Minimization Measures,
  • You will provide regulatory expertise to other sectors within the scope of the activities and products assigned.



Minimum Requirements :

  • Pharmacist or with a scientific background or with a Master degree.
  • You have at least 3 years of experience in Regulatory Affairs.
  • You are organized and rigorous with excellent interpersonal and writing skills (French and English).
  • Autonomous, you know how to manage priorities and demonstrate a spirit of analysis and synthesis.
  • You have an operational level of English (comprehension and writing).




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