Regulatory Affairs Project Manager (Pharmacist)

• 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.

• 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)

At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.

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. Requirements • 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 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’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. Originally posted on Himalayas Regulatory-Affairs, Global-Regulatory-Submissions, Regulatory-Operations, Pharmaceutical-Regulatory, Regulatory-Consulting, Regulatory-Affairs-Project-Manager, Regulatory-Project-Manager, Pharmaceutical-Project-Manager, Regulatory-Affairs-Manager, Senior-Pharmaceutical-Project-Manager, Regulatory-Affairs-Project-Management