Submission Lead – Structured Data

Sanofi; Marcy-l'Étoile; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Team management

Stakeholder collaboration

Communication

Ausbildung

Life Sciences degree

Information Technology degree

Tools

RIM Systems

Jobbeschreibung

• Lead structured data operations end-to-end, ensuring timely and compliant submissions to Health Authorities worldwide.
• Manage and develop a team of structured data specialists to meet all compliance requirements and quality standards.
• Drive the global implementation of IDMP standards and monitor changes to regulatory data requirements.
• Represent Sanofi in working groups with Health Authorities and industry partners to shape regulatory innovation.
• Oversee data quality control and track Key Performance Indicators (KPIs) to ensure on-time submissions.
• Set up and monitor service agreements with vendors and contractors to ensure operational excellence and timely delivery.
• Provide expertise during audits and support inspection processes with required documentation and responses.
• Work with stakeholders to continuously improve structured data processes and build team expertise.

Requirements

• Extensive pharmaceutical regulatory affairs and/or regulatory data background
• Proven hands-on experience in structured data submission applications and RIM systems
• Strong knowledge of medicinal product information and global information standards
• Understanding of global regulatory environment and Regulatory Information Management (RIM) Systems
• Knowledge of pharmacovigilance regulations preferred
• Degree in Life Sciences, Information Technology, or related field is preferred
• Fluent English (spoken and written) required; Additional language knowledge is a plus

Core Competencies

Demonstrates expertise in leading structured data operations and managing compliance with global regulatory standards. Proven ability to drive the implementation of IDMP standards and enhance data quality through effective team management and stakeholder collaboration.

Highest-signal resume keywords

• Pharmaceutical Regulatory Affairs
• Structured Data Submission Applications
• Regulatory Information Management (RIM) Systems
• Medicinal Product Information
• Data Quality Control

Hard Skills

• Structured Data Operations
• Regulatory Data Background
• IDMP Standards Implementation
• Key Performance Indicators (KPIs)
• Audit Support
• Pharmacovigilance Regulations
• Life Sciences Degree
• Information Technology Degree

Soft Skills

• Team Management
• Stakeholder Collaboration
• Communication

Industry Keywords

• Global Regulatory Environment
• Compliance Requirements
• Health Authorities
• Regulatory Innovation
• Service Agreements