Cyrille Hubert

Regulatory Information Project Manager @SERB Pharmaceuticals

Ville de Paris, FR

Regulatory Information Management:• Ensure efficient access and utilization of regulatory systems.• Develop and implement best practices for system integration and usage.• Define data entry standards and ensure reliable data management (xEVMPD, IDMP, ESMP, SPOR, PLM).Application Management:• Manage, configure, and validate regulatory systems (Veeva RIMS, Mono eCTD office, etc.).• Oversee release management, API integration, configuration (IT), and GxP validation (IT QA).Regulatory Compliance:• Create and maintain regulatory master data in compliance with IDMP regulations, local, and company requirements.• Prepare and maintain quality documents.• Develop, monitor, and maintain KPIs.• Provide training and act as a key expert in regulatory information support.QA/IT/Vendor Management:• Serve as the primary interface with company QA & IT services and system vendors.• Oversee relationships with technology vendors and service providers to ensure high-quality solutions and services.

Lycée Saint-Vincent de Rennes

Baccalauréat Série S

Université de Rennes I

Doctor of Pharmacy - PharmD, Pharmacy

Université de Rennes I

Thesis in Pharmaceutical Regulatory Affairs, Pharmacy

University of Strasbourg

Master’s Degree (year 2), Pharmaceutical Law and Regulatory Affairs