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About the Role

Gilead is dedicated to creating a healthier world by tackling diseases like HIV, viral hepatitis, COVID-19, and cancer. We seek passionate individuals to join our mission of developing life-changing therapies and ensuring global access. As a people leader, you will be key in evolving our culture, creating an inclusive environment, and empowering employees to achieve their aspirations.

Responsibilities

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, Japan Package Insert (Labeling), and 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.
Handle the submission of Japan Package Insert to PMDA.
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.
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.
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 external vendors used for labeling.

Requirements

Bachelor's degree or higher in Pharmacy, Life Sciences, Medicine, or a related scientific discipline.
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.
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.
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.
Native-level Japanese proficiency.
Business-level English proficiency, including the ability to participate in global meetings and prepare regulatory documentation.
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.

Skills

Labeling strategy development
CTD M1.8 authoring
Japan Package Insert authoring
Regulatory authority engagement
Strategic guidance
Regulatory assessment
Benefit-risk communication
PMDA submission handling
Cross-functional collaboration
Global labeling alignment
Project management
Scientific writing
Document authoring
Analytical skills
Risk assessment
Organizational skills
Influencing stakeholders
Communication skills
Presentation skills
Veeva RIM
PMDA JPI website management

Location

Japan

Work Type

Full-time

Experience Level

Minimum 7 years of experience in Regulatory Affairs
Minimum 5 years of direct experience in labeling
Experience leading cross-functional projects
Experience leading the team

Education Level

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

About the Company

For more than 35 years, Gilead has tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe.
We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations.
Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.