R&D
Where your curiosity drives the
miracles of
science
R&D - GRA - Regulatory Affairs Manager -BJ
At a glance
Bring your curiosity to a team where deep immunoscience meets cutting-edge innovation. Across oncology, rare diseases, neurology, and vaccines, you’ll work at the intersection of lab science and AI-powered discovery — all while collaborating across boundaries to turn breakthrough ideas into real-world impact. Whether you want to deepen your scientific expertise or grow as a leader, you’ll find the opportunity here.
Be accountable for the regulatory strategy implementation by regulatory submission / approval for the assigned projects
• Lead regulatory execution for the assigned products to ensure the successful submission/approval on time
• Work with related functions at GRA and China region to implement the regulatory strategy of the responsible projects for the region, aligned with global strategy and regional business strategy
• Collaborate with related functiona at corporate, IA and work with affiliates to support the regulatory activities in the region
• Ensure the high-quality submission with effective communication with agency and internal stakeholders/peers for the assigned projects/tasks
● Be responsible to contribute and facilitate regulatory strategy for the responsible projects with the guidance of senior regulatory leaders
• Work with related functions at global and China region to develop the regulatory strategy of the responsible projects for the region, aligned with global strategy and regional business strategy
• Work across project team and related workstreams to evaluate regulatory risk and identify the mitigation plan
• Provide Regulatory strategy and professional support to cross-functions to ensure business success
• Provide regulatory strategy and assessment/inputs to BD strategical projects and environment mapping
● Be accountable for HA interaction for regulatory strategy assessment with the guidance of senior regulatory manager
• Build up strong partnership with relevant government agency
• Monitor and provide the professional assessment to the trend of regulatory policy, regulations and the new requirements and its implications
• Collect regulatory intelligence and provide the analysis
● Ensure regulatory compliance and work in compliance way
Education:
• Master degree or above in Pharmacy, Medical, Biology or related field (Bachelor acceptable in special cases)
Experience & knowledge:
• 5years+ RA experience and 6 year’ industry experience is plus
• Experience in handling complex regulatory submission including new product and marketed products, Bio product registration testing, and etc.
• Good track record; *independent working; experience in drug/biologic manufacturing is a plus
Core competencies:
• Good computer skill in EXCEL, POWERPOINT and WORD and AI tool;
• Good interpersonal communication skill
• Chinese and English (proficiency level) skill both in spoken and written
nullPursue 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.
Watch 'One day at Sanofi' and check out our Diversity Equity and Inclusion initiatives at sanofi.com
Final compensation will be determined based on factors such as experience, skills, expertise, location, and others. Employees may be eligible to participate in company employee benefit programs.
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Why work with us
- Expand your horizons. Grow through curiosity, with support to move, learn, and lead in a culture that champions mentorship, mobility, and bold development.
- Accelerate results with technology. Harness the power of AI and automation to push scientific boundaries and reimagine what's possible in drug discovery.
- Impact through inclusive innovation. Help deliver better science and fairer outcomes by driving inclusive research that reaches more people, in more meaningful ways.
- Turn patient needs into breakthrough science. Drive scientific breakthroughs that start with patient needs – and end in treatments that change lives.
Meet Nils Libert, Associate Scientist
Meet Nils Libert, an Associate Scientist in Belgium, where he plays a key role in advancing groundbreaking research. Learn how his work helps drive innovation, uncover new scientific possibilities, and contribute to life-changing treatments that impact patients around the world.
"At Sanofi, we are building an R&D engine powered by the best science, digital innovation, and a commitment to transforming the lives of patients around the world."
Houman Ashrafian
EVP & Head of R&D
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Discover how we're reshaping the future of medicine through immunoscience – unlocking bold, cross-disease breakthroughs that were unimaginable just a decade ago.
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