En un coup d'œil
- Missions: Dirigez les opérations de données structurées et assurez des soumissions conformes aux autorités sanitaires.
- Entreprise: Sanofi, leader dans l'innovation réglementaire et la conformité.
- Avantages: Salaire compétitif, avantages santé, travail à distance et développement professionnel.
- Autres infos: Environnement dynamique avec des opportunités de croissance de carrière.
- Pourquoi ce job: Impactez le secteur pharmaceutique en améliorant les processus de données structurées.
- Qualifications: Expérience en affaires réglementaires et soumissions de données structurées requise.
Le salaire estimé est compris entre 74250 - 90750 € par an.
- 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
- #J-18808-Ljbffr
Submission Lead – Structured Data employeur : Sanofi
Sanofi est un employeur de choix, offrant un environnement de travail dynamique et collaboratif au sein de son bâtiment de formulation liquide. Avec un fort accent sur le développement professionnel, les employés bénéficient d'opportunités de croissance et de formation continue, tout en contribuant à des projets de qualité qui ont un impact significatif sur la santé publique. La culture d'entreprise valorise l'innovation et l'engagement, faisant de Sanofi un lieu idéal pour ceux qui cherchent à faire une différence dans le secteur pharmaceutique.
