Associate Director – Japan Labelling Lead - Regulatory Affairs

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Job Description
 

JOB DESCRIPTION – ESSENTIAL DUTIES

<Key Responsibilities>

Strategic Labeling Leadership

·        Develop and drive the Japan labeling strategy across the product lifecycle, including JNDA, sJNDA and post-marketing maintenance activities.

• Act as the person in charge of CTD M1.8 as well as Japan Package Insert (Labeling) and other related documents.
• Serve as the Japan regulatory authority on labeling matters and provide strategic guidance to senior leadership and cross-functional stakeholders.
• Evaluate emerging regulatory, scientific, and competitive developments to proactively identify potential implications for product labeling.
• Ensure alignment of Japan labeling with Global Core Data Sheets (CCDS/CCSI) while optimizing product differentiation and compliance within the Japanese regulatory environment.

·        Lead benefit-risk communication strategies through labeling and related product information documents.

·        Handles the submission of Japan Package Insert to PMDA

Regulatory Leadership and Health Authority Engagement

·        Lead regulatory assessment and decision-making related to labeling updates arising from safety signals, new clinical data, regulatory actions, and business priorities.

• Collaborate with Patients Safety and An-seki (Safety Manager of MAH) based on the regulatory assessment.
• Provide strategic oversight for PMDA interactions concerning labeling matters, including consultations, negotiations, and responses to regulatory inquiries.
• Influence regulatory outcomes by developing clear, evidence-based positions and risk mitigation strategies.

·        Represent Japan Regulatory Affairs in global governance forums and labeling committees.

Cross-Functional and Global Collaboration

·        Partner with Global Labeling and Regulatory, Pharmacovigilance, Clinical Development, Medical Affairs, Commercial, Market Access, Legal, and Quality organizations to drive alignment on labeling strategies and implementation plans.

• Lead cross-functional labelling governance processes to enable efficient review, approval, and execution of labeling updates.
• Act as a key liaison between Japan and Global teams, ensuring local regulatory perspectives are appropriately represented in global decision-making.

·        Support R&D teams by providing strategic regulatory labeling input throughout development and lifecycle management.

·        Lead the promotion material updates in accordance with JPI update.

Operational Excellence and Compliance

·        Ensure compliance with all applicable Japanese regulatory requirements, corporate standards, and internal policies.

• Provide oversight of labeling processes, metrics, and inspection readiness activities.
• Lead continuous improvement initiatives to enhance labeling quality, efficiency, and compliance.
• Mentor and develop regulatory professionals while fostering a culture of accountability, collaboration, and excellence.
• Manage the external vendors which are used for the labelling

<Qualification>

Required Qualifications

Education

·        Bachelor's degree or higher in Pharmacy, Life Sciences, Medicine, or a related scientific discipline.

Experience

·        Minimum 7 years of experience in Regulatory Affairs within the pharmaceutical industry.

• Minimum 5 years of direct experience in labeling, package insert management, or related regulatory activities.
• Demonstrated experience interacting with PMDA and managing regulatory communications.
• Hands-on Experience of M1.8 and PMDA Package Insert Website.
• Proven experience supporting regulatory submissions and post-approval regulatory maintenance.

·        Experience leading cross-functional projects and managing multiple priorities simultaneously.

Technical Knowledge

·        Strong understanding of Japanese pharmaceutical regulations and regulatory requirements.

• In-depth knowledge of package inserts requirements, electronic labeling, and post-marketing regulatory obligations.
• Working knowledge of GVP, GPSP, RMP, and relevant ICH guidelines.
• Thorough understanding of pharmaceutical product development and lifecycle management.

·        Knowledge and Experience of handling Veeva RIM for labelling and PMDA JPI website.

Skills and Competencies

·        Excellent scientific writing and document authoring skills, especially for M1.8.

• Strong analytical and risk assessment capabilities.
• Proven project management and organizational skills.
• Ability to influence stakeholders and drive alignment across functions.

·        Strong communication and presentation skills.

Language Requirements

·        Native-level Japanese proficiency.

·        Business-level English proficiency, including the ability to participate in global meetings and prepare regulatory documentation.

Preferred Qualifications

·        Experience in Oncology, Virology, Cell Therapy, Rare Diseases.

• Experience in Leading the team
• Global regulatory or global labeling experience.
• Experience participating in Labeling Governance Committees or Global Product Teams.
• Experience with accelerated development pathways, including Priority Review, Orphan Drug, and SAKIGAKE etc.
• Experience using Veeva Vault RIM and other regulatory information management systems.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.