Global Regulatory Submission Lead

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

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.