About the job
We are a worldwide leader in human Vaccines for 100 years. We develop and produce a broad range of high-quality vaccines to protect people around the world from severe diseases at each and every stage of life. We have continued strong growth and best in class products to protect against many diseases such as flu, meningitis, polio, pertussis, bronchiolitis and much more. We improve people’s lives by developing innovative vaccination solutions against many diseases.
We innovate in vaccines manufacturing through digitalization and we engage in partnerships for disease prevention, to sustainably maximize vaccination impact.
We give employees the opportunity to grow and encourage them to build diversified career paths within the Sanofi organization.
Our Team:
The Quality Regulatory department serves as the strategic bridge between regulatory compliance and operational excellence across our manufacturing sites. Our mission is to ensure all commercialized products meet the highest regulatory standards while enabling business growth through proactive regulatory strategy. We lead regulatory lifecycle management, drive continuous improvement in quality systems, and foster a culture of compliance excellence. What makes our team unique is our ability to balance strategic regulatory intelligence with hands-on operational support, ensuring seamless product launches and sustained market presence globally.
Main responsibilities:
- Lead regulatory compliance strategy ensuring alignment between approved registrations and site operations
- Drive market authorization activities worldwide, including territory extensions, transfers, and post-license commitments
- Oversee batch release processes and ensure timely product submissions and approvals
- Lead preparation and execution of global quality audits and regulatory inspections
- Manage internal and supplier audit programs from planning through follow-up
- Direct change control assessments and define regulatory strategies with cross-functional teams
- Oversee CMC documentation and dossier preparation for regulatory submissions
- Lead semi-annual quality performance reviews and site quality planning
- Drive implementation of quality maturity frameworks and continuous improvement initiatives
- Build and develop a high-performing Quality Regulatory team
About you
• Experience: Proven track record in pharmaceutical regulatory affairs and quality management with demonstrated leadership in managing complex regulatory compliance programs
• Soft skills: Strategic thinking, executive presence, strong leadership and team development capabilities, excellent stakeholder management, decision-making under pressure, change management expertise
• Technical skills: Deep expertise in regulatory affairs, quality systems, chemistry manufacturing and controls documentation, global regulatory submissions, audit management, and pharmaceutical regulations across multiple markets
• Education: Bachelor's degree in Pharmacy, Chemistry, Biology, or related scientific field; advanced degree preferred
• Languages: Fluency in both Spanish and English is mandatory
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, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
