**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 ! **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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)