Global Regulatory Data Lead: IDMP & Submissions

Sanofi; Marcy-l'Étoile; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Sanofi seeks a leader to oversee structured data operations and ensure compliant submissions to health authorities worldwide. You will manage a team, drive IDMP implementations, and coordinate with stakeholders to maintain data quality and regulatory compliance.

The role focuses on global data standards, regulatory information management, and continuous process improvement within a high-stakes environment.

Qualifications

• Extensive pharmaceutical regulatory affairs or regulatory data background.
• Hands-on experience with structured data submission applications and RIM systems.
• Strong knowledge of medicinal product information and global information standards.
• Understanding of global regulatory environment and RIM systems.
• Knowledge of pharmacovigilance regulations preferred.

Responsabilités

• Lead structured data operations end-to-end with timely, compliant health authority submissions.
• Manage and develop a team of structured data specialists to meet standards.
• Drive global implementation of IDMP standards and monitor regulatory data requirements.

Connaissances

Team management

Stakeholder collaboration

Communication

Formation

Life Sciences degree

Information Technology degree

Outils

RIM Systems

Description du poste

Sanofi seeks a leader to oversee structured data operations and ensure compliant submissions to health authorities worldwide. You will manage a team, drive IDMP implementations, and coordinate with stakeholders to maintain data quality and regulatory compliance.

The role focuses on global data standards, regulatory information management, and continuous process improvement within a high-stakes environment.