Job title: International Regulatory Strategist
Location: Dubai, UAE / Cairo, Egypt / Ciudad de México, Mexico / São Paulo, Brazil
About the job
As International Regulatory Strategist within our Global Regulatory Team, you'll provide regulatory expertise and deep international markets expertise to identify early opportunities and risks, develop comprehensive mitigation plans, and ensure seamless integration into global regulatory strategy across Brazil, Africa MCO, Eurasia & Turkey MCO, SEA & India MCO, AUNZ & KR MCO, LATAM MCO, and key markets including Greater Gulf MCO, Hong Kong and Taiwan . Ready to get started?
Ready to push the limits of what's possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world.
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:
- Drive early engagement with international markets countries through proactive knowledge sharing on clinical development programs and key project milestones, ensuring local teams are ready to partner in local launch readiness and excellence discussions
- Build robust scenario and comprehensive regulatory strategies tailored to regional requirements and market-specific considerations while standardizing dossier preparation by leveraging the global dossier as the foundation
- Partner with countries demonstrating commercial interest to develop ready-to-deploy strategies that can be executed upon business case approval
- Act as the first line of response to health authorities questions for international regional markets, leading the draft of responses with collaboration of subject matter experts
- Maintain deep understanding of international regulatory landscapes and emerging changes, translate complex regulatory updates into actionable insights, and assess their potential impact on global regulatory strategies
- Serve as regional regulatory lead and point of contact with local affiliates for pre-submission meetings with Health Authorities on projects/products in their remit, and may lead international country Health Authority meetings and preparations as designated
- Leverage regulatory expertise to lead the definition of international regulatory strategy, enabling and driving execution of aligned regulatory strategy for assigned projects as a key member of the Global Regulatory Team
- Contribute to development of harmonized, One Sanofi regulatory voice through participation in appropriate committees and forums at the direction of the Global Regulatory Lead
- Actively contribute to Global Regulatory Meetings and ensure respective regulatory team members have information necessary to contribute to development and execution of Global Regulatory Strategy
- Proactively contribute to development of Global Regulatory Project Strategy (GRPS) and ensure alignment with core product labeling for products in development and life cycle management
- Liaise with clinical, commercial, and other internal business partners in partnership with the Global Regulatory Lead to enable successful regulatory outcomes in international regions
- Identify regulatory risks and propose mitigations in collaboration with the Global Regulatory Lead to cross-functional teams using Sanofi standardized methodologies
- Support operational and compliance activities for assigned deliverables, develop and execute regulatory submission planning activities, including generating submission content plans, submission tracking, and document management
About you
- Experience: Minimum of 5 years' experience in Regulatory Affairs with experience working within an international company with a complex organizational environment. Comprehensive knowledge and expertise of international regulations required. Demonstrated ability to handle multiple projects/deliverables simultaneously preferred.
- Soft and technical skills: Emerging understanding of pharmaceutical and clinical development of drugs and/or novel biologics products; demonstrates business acumen, leadership, influencing and negotiation skills; effective communication skills with strong oral and written presentation skills; ability to work with multifunctional and multicultural teams in a matrix organization; ability to act as change agent, fostering simplification and efficiency mindset; ability to foresee and respond to potential problems and opportunities with thoughtful risk-taking approach; proactive contribution with curiosity and openness to diverse perspectives
- Education: Physician, Pharmacist, Veterinarian or scientific background (BS/BA degree in a relevant scientific discipline or MSc in Biology, Life Science, or related field)
- Languages: Fluency in English is required; additional languages based on regional assignment are an advantage
Why choose us?
- Make your work count by supporting a company that brings life-changing treatments to millions — and is committed to doing right by patients, communities, and the planet
- Drive progress from within by helping simplify, scale, and modernize how a global biopharma business delivers smarter, faster, and more sustainably
- Support teams across science, medicine, and operations by building better systems, shaping bold strategies, and enabling innovation at speed
- Make an impact across borders and functions, collaborating with leaders to turn complex challenges into real-world solutions
- Advance your career through stretch roles, cross-functional moves, and development opportunities designed to match your ambition
- Thrive in inclusive, high-performing teams where every role matters and every voice helps shape what's next
- Work directly with international markets across multiple regions, shaping regulatory strategies that enable global product launches and patient access
Pursue Progress. Discover Extraordinary.
Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what's never-been-done-before. You'll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people's lives? Let's Pursue Progress and Discover Extraordinary – together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.
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!
