Regulatory Affairs Project Manager (Pharmacist)

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 : Lead the planning, coordination, and execution of global regulatory submission strategies across key markets (FDA, EU, China, and Japan). Manage dossier preparation, compilation, and submission activities, ensuring compliance with regulatory requirements and timelines. Coordinate interactions with external service providers and publishing vendors to ensure successful dossier delivery and submissions. Identify submission risks, proactively address resource constraints, and support problem-solving to maintain project timelines. Drive regulatory submission activities throughout the entire product lifecycle, from First-in-Human (FIH) studies to license withdrawal. Partner with Global Regulatory Leads, Regional Regulatory Leads, and cross-functional teams to develop and execute global regulatory roadmaps. Build and maintain project management tools, submission schedules, dashboards, and milestone tracking to support regulatory governance. Oversee the preparation of reference dossiers (Modules 2-5), ensuring alignment across global and local regulatory requirements. Monitor submission progress, manage dossier updates, coor