Regulatory Affairs Project Manager (Pharmacist)

Excelya; Saclay; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Excelya is seeking a Global Regulatory Submission Manager Consultant to lead and coordinate regulatory submission activities across the product lifecycle, from FIH development through post-approval maintenance and license withdrawal.

In this senior role, you will drive planning and execution across FDA, Europe, China, and Japan, ensuring high-quality dossiers delivered on time and compliant with global requirements, working closely with Medical Writing, Clinical Development, and R&D Operations.

Qualifications

• Proven experience in global regulatory submissions and operations.
• Strong knowledge of eCTD dossier preparation and publishing.
• Experience with FDA, EMA, China, and Japan regulatory requirements.
• Excellent project management and stakeholder coordination.
• Fluent in English.

Responsabilités

• Lead global regulatory submission strategies across key markets (FDA, EU, China, Japan).
• Manage dossier preparation, compilation, and submission activities on time.
• Coordinate with external providers and publishing vendors for submissions.
• Identify submission risks and address resource constraints to maintain timelines.
• Drive submissions throughout product lifecycle from FIH to license withdrawal.
• Collaborate with Global/Regional Regulatory Leads and cross-functional teams.
• Develop and maintain submission schedules, dashboards, and milestone tracking.
• Oversee reference dossiers (Modules 2-5) alignment with global/local requirements.
• Monitor progress, update dossiers, respond to health authority questions.
• Work with Medical Writing, Clinical Development, R&D Operations, Tech Management, partners.

Connaissances

Regulatory submissions

Regulatory operations

eCTD preparation

Project management

Cross-functional collaboration

English fluency

Description du poste

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

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.