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.

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