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, coordinate responses to health authority questions, and ensure regulatory database compliance. • Act as a key member of the Global Regulatory Team, collaborating closely with Medical Writing, Clinical Development, R&D Operations, Technical Management, and external industry partners.