Regulatory Submissions

Il y a 5 jours

Geel, Antwerpen, Belgique 7555-Janssen Pharmaceutica NV Legal Entity Temps plein 83 000 € - 138 000 €/an

Johnson & Johnson is seeking a Submissions & Regulatory Intelligence Manager within Integrated Data Analytics & Reporting (IDAR) to lead clinical data standards initiatives and support regulatory submissions across multiple countries. You will collaborate with data management, biostatistics, programming, and regulatory affairs teams to ensure compliant, timely submission deliverables.

The role emphasizes leadership, deep regulatory knowledge (GCP/ICH, SDTM/ADaM), and the ability to coordinate