Assoc Director, Regulatory Affairs

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve 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.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

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.

About Us

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.