Regulatory Affairs Project Manager
At Excelya, where Audacity, Care, and Energy are at the core of everything we do, we are seeking a Global Regulatory Submission Manager Consultant to join our dynamic team.
This role is responsible for leading and coordinating global regulatory submission activities across the entire product lifecycle, from First-in-Human (FIH) development through post-approval maintenance and license withdrawal. As a key member of the Global Regulatory Team, you will drive submission planning and execution, ensuring high-quality dossiers are delivered on time and in compliance with global regulatory requirements across major markets including the FDA, Europe, China, and Japan.
The Regulatory Affairs Department is looking for a senior consultant with strong expertise in regulatory operations, dossier management, and global submission coordination
Key responsibilities :