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
About the job
As Submission Lead for Structured Data within our Global Submission Management (GSM) team, you'll lead the implementation of cutting-edge regulatory data standards and ensure timely, compliant submissions to Health Authorities worldwide. Ready to get started?
Join Sanofi's dynamic Global Submission Management (GSM) team, part of Global Regulatory Operations (GRO), where a diverse group of regulatory professionals work collaboratively across geographies to ensure timely, accurate, and compliant submissions to Health Authorities worldwide. You'll play a key role in ensuring that medicinal product information is submitted in standardized, structured formats — directly contributing to patient safety and regulatory efficiency at a global scale.
About Sanofi:
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.
Main responsibilities:
- 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.
What we offer you:
- 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.
About you
Experience:
- 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
Soft & technical skills:
- 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.
Education:
- Degree in Life Sciences, Information Technology, or related field is preferred
Languages:
- Fluent English (spoken and written) required;
- Additional language knowledge is a plus
Why choose us?
- 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.
#LI-FRA #LI-Hybrid
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
The salary range for this position is :€54 400,00 - €72 533
Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.
