Global Regulatory Submissions Leader

Excelya; France; Hybride; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Excelya is seeking a Global Regulatory Submission Manager Consultant to lead planning and execution of regulatory submissions across FDA, EU, China, and Japan. You will drive dossier preparation, ensure compliance, and coordinate with external vendors to meet timelines.

The role requires senior expertise in regulatory operations, eCTD processes, and global health authority interactions, with a strong emphasis on project governance and cross-functional collaboration.

Qualifications

• 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).

Responsabilités

• 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 FIH studies to license withdrawal.
• Partner with Global 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.
• Oversee the preparation of reference dossiers (Modules 2-5), ensuring alignment across global 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 with Medical Writing, Clinical Development, R&D Operations, and external partners.

Connaissances

Global regulatory submissions

Regulatory operations

eCTD dossier preparation

Regulatory requirements knowledge (FDA

Project management

Stakeholder coordination

Multinational/cross-functional work

Risk assessment & problem solving

English fluency

Description du poste

Excelya is seeking a Global Regulatory Submission Manager Consultant to lead planning and execution of regulatory submissions across FDA, EU, China, and Japan. You will drive dossier preparation, ensure compliance, and coordinate with external vendors to meet timelines.

The role requires senior expertise in regulatory operations, eCTD processes, and global health authority interactions, with a strong emphasis on project governance and cross-functional collaboration.