Submission Lead for Structured Data

Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l'international, l'anglais étant la langue de travail.

Job title: Submission Lead for Structured Data

• Location: Marcy l' Étoile or Gentilly

• 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.

• A fixed salary over 12 months, supplemented by a short-term incentive as well as a collective variable compensation based on Sanofi Group results.
• Because taking care of our employees is also our mission: 31 days of paid leave + RTT depending on your status, remote work up to 2 days/week, quality health insurance, public transport coverage up to 80%, extended maternity/parental leave (18/14 weeks), Group Savings Plan & PERCOL with employer matching, PERO, numerous CSE benefits, internal and international mobility opportunities, learning & development opportunities, and many other benefits to discover here.

• Extensive pharmaceutical regulatory affairs and/or regulatory data background, with 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

• Strong influencing abilities to drive compliance across affiliate organizations and educate teams on structured data submission subjects.
• Excellent organizational and project management skills to handle complex, multi-stakeholder initiatives;
• Continuous improvement mindset with focus on process optimization and subject matter expertise development.

• Degree in Life Sciences, Information Technology, or related field is preferred

• Fluent English (spoken and written) required;
• Additional language knowledge is a plus

• Turn bold ideas into breakthrough launches, with multiple new therapies planned through 2030 and beyond.
• Lead and be the Subject Matter Expert for the global transition to IDMP standards - a transformative regulatory initiative that modernizes data exchange with Health Authorities worldwide - and become a subject matter expert (SME) in this groundbreaking implementation.
• Drive meaningful impact on priority portfolio regulatory submissions with visibility into a strategically important business area.
• Develop your career with access to cross-functional moves, and opportunities to grow across a global regulatory network.
• Collaborate with leading regulatory experts, data specialists, and Health Authorities in a purpose-driven community dedicated to patient safety.
• Thrive in inclusive, high-performing teams where every role matters and every voice helps shape what's next.
• Enjoy outstanding benefits, including flexible working options, comprehensive healthcare, and well-being programs designed to help you thrive.