R&D
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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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