Global Regulatory Submissions Leader for Lifecycle Strategy

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.