[Hiring] Regulatory Affairs Project Manager @Excelya

Role Description

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.

• 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.

Qualifications

• Proven experience in global regulatory submissions and regulatory operations.
• Strong knowledge of eCTD dossier preparation, publishing, and submission processes.
• Experience with FDA, EMA, China, and Japan regulatory requirements.
• Excellent project management and stakeholder coordination skills.
• Ability to manage multiple priorities and meet challenging deadlines.
• Strong risk assessment and problem-solving capabilities.
• Experience working in cross-functional and international environments.
• Proactive, organized, and detail-oriented mindset.
• Excellent communication and collaboration skills.
• Fluent in English (written and spoken).

Benefits

• At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.
• We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience.
• Our one-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 care means 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.