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

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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!