Regulatory Affairs Project Manager H/F - Excelya

Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of full-service CRO, FSP, and Resourcing solutions guided by our values Energy, Care and Audacity.Founded in 2014 and headquartered in Paris, France, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas.We take a one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.Excelya is committed to helping our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together.
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 coordinationKey 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.

Why Join Us?At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.Here's what makes us unique-We are a young, ambitious health company representing 900 Excelyates, driven to become Europe'sleading mid-size CROwith thebest employee experience. Ourone-stop provider service model-offering full-service, functional service provider, and consulting-enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey.Excelling with caremeans benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.Proven experience in global regulatory submissions and regulatory operationsStrong knowledge of eCTD dossier preparation, publishing, and submission processesExperience with FDA, EMA, China, and Japan regulatory requirementsExcellent project management and stakeholder coordination skillsAbility to manage multiple priorities and meet challenging deadlinesStrong risk assessment and problem-solving capabilitiesExperience working in cross-functional and international environmentsProactive, organized, and detail-oriented mindsetExcellent communication and collaboration skillsFluent in English (written and spoken)