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.

• 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)