Global Regulatory Submissions Leader for Lifecycle Strategy

Excelya Group; Saclay; On-site; EUR 90,000 - 130,000; Full time

Job summary

Excelya Group in France seeks a Global Regulatory Submission Manager Consultant to lead and coordinate global regulatory submission activities across the product lifecycle, from First-in-Human (FIH) development through post-approval maintenance and license withdrawal.

You will drive submission planning, ensure high-quality dossiers for FDA, EU, China and Japan, oversee reference modules 2-5, and collaborate closely with Medical Writing, Clinical Development, R&D Operations and external partners.

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).

Responsibilities

• Lead global regulatory submission strategies across FDA, EU, China and Japan.
• Manage dossier preparation, compilation, and submission activities.
• Coordinate with external vendors to ensure dossier delivery.
• Identify submission risks and address resource constraints.
• Drive regulatory submission activities from FIH to license withdrawal.
• Partner with Global/Regional Regulatory Leads and cross-functional teams.
• Build and maintain project management tools, schedules, dashboards.
• Oversee preparation of reference dossiers (Modules 2-5).
• Monitor submission progress and respond to health authority questions.
• Collaborate with Medical Writing, Clinical Development, R&D Ops and others.

Skills

Global regulatory submissions

Regulatory operations

eCTD dossier prep

FDA EMA China Japan regs

Project management

Stakeholder coordination

Prioritization & deadlines

Risk assessment & problem-solving

Cross-functional/intl work

English communication

Job description

Excelya Group in France seeks a Global Regulatory Submission Manager Consultant to lead and coordinate global regulatory submission activities across the product lifecycle, from First-in-Human (FIH) development through post-approval maintenance and license withdrawal.

You will drive submission planning, ensure high-quality dossiers for FDA, EU, China and Japan, oversee reference modules 2-5, and collaborate closely with Medical Writing, Clinical Development, R&D Operations and external partners.