# Regulatory Affairs Project Manager

> Excelya · Saclay, France (Remote) · Full-time · Posted 2026-08-10

**Workplace:** remote

**Department:** Regulatory Affairs - Resourcing

## 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.

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.

## Apply

[Apply at Excelya](https://apply.workable.com/excelya/j/D2BFC05E5F/apply)

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