Global Regulatory Submissions Leader for Lifecycle Strategy

Il y a 2 jours

Saclay, Île-de-France Excelya Group Temps plein

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. xuezdbg


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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.