
R&D
Where your curiosity drives the
miracles of
science
Regulatory Labeling Manager
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.
Role & Responsibilities
The Labeling Manager is responsible for the development, maintenance, and revision of Japan Prescribing Information as labeling for Japan (J-PI) for products. This role ensures compliance with relevant regulations and aligns with global labeling strategies. The Labeling Manager will develop strategies, prepare and submit PI drafts to the PMDA, and manage related data and information. Responsibilities of the role include management of processes, vendors, budgets, and stakeholders.
Development and Maintenance of Prescribing Information for Japan (J-PI)
Prepare and revise J-PI for the products with reasonable rationale based on strategies and sciences in accordance with relevant regulations:
Develop strategy and J-PI
Take actions related to requirements from the local Health Authorities (HA)
Respond to Company Core Data Sheet (CCDS) updates
Prepare J-PI drafts and submit to PMDA with related materials such as CCDS and SER
Respond to PMDA’s inquiries
Handle J-PI notification
Manage data and information related to J-PI revision using system tools
Transfer PI-related information during business succession
Manage PI-related information for pruning products
Follow up on e-labeling implementation
Consult with PMDA for “New format” revision drafts
PI-related Materials
Create, consult with PMDA for, and revise PI-related materials for marketed products such as Medication Guides for Patients
Management of Processes, Vendors, Budgets, and Stakeholders
Ensure timely and efficient management of labeling operations and related vendors
Monitor labeling budgets and collaborate with relevant departments
Engage stakeholders across functions to support labeling processes
Activities Related to Safety Measures
Participate in Drug Safety Committee (DSC) led by Pharmacovigilance
Support GVP inspections
Building Cooperative Relations with Internal Functional Groups
Provide information on creation or revision of J-PI to Manufacturing & Supply in a timely manner
Maintain good relationships with Medical Affairs to ensure scientific consistency in materials
Actively participate in key meetings such as Product Management Review Meeting as a regulatory representative
Global Labeling
Align with Global Labeling group for J-PI through close communication
Contribute to Global Labeling initiatives such as end-to-end (E2E) labeling
Knowledge, Skills & Competencies / Language
Good working knowledge in development and post-marketing regulatory processes
Strong negotiation skills for discussion with cross-functional stakeholders
Ability to build strong relationships with relevant functions
Demonstrated knowledge of regulatory requirements and/or guidance
Good communication skills, both verbal and written, in Japanese and English
Familiarity with labeling-related global regulatory requirements (e.g., US and EU)
Qualifications
Business-level English proficiency (e.g., TOEIC score of 850 or above)
Experience in regulatory affairs
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!
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
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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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