Regulatory Affairs Director

At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads 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 were 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

Key Responsibilities

• Lead the development and implementation of comprehensive regulatory strategiesfor assigned products and programs in oncology and inflammation from pre-IND/IND NDA/BLA through approval and post-marketing phases ensuring alignment with global plans and local regulation requirements.
• Serve as theChina Affiliate Regulatory TA Leadfor complex or high-priority molecules indications or development programs providing strategic input to cross-functional teams including Clinical Development CMC Pharmacovigilance and Commercial.
• Drive end-to-endNDA/BLA submissions and regulatory approvals including leading cross-functional teams in dossier preparation responding to HA questions managing RTQ processes and supporting inspection readiness.
• Lead and manage all interactions with CDE/NMPA and other local health authorities including pre-IND pre-NDA major milestone meetings and ad hoc communications; act as the primary regulatory point of contact for regulatory authorities in China.
• Oversee timely and compliant submission ofclinical trial applications amendments annual reports and other trial-related documentsto ensure uninterrupted clinical development.
• Guide the preparation of key regulatory documents including briefing packages meeting requests responses to information requests and risk-benefit analyses.
• Proactively monitor and interpret evolvinglocal regulatory requirements guidance and policies and ensure rapid integration into China regulatory strategies; contribute to shaping new regulations through constructive engagement.
• Provide regulatory input intopromotional materials review and lifecycle planning ensuring compliance with approved labeling and local advertising regulations.
• Represent Regulatory Affairs incross-functional brand teams and internal governance committees contributing to product positioning and launch readiness.
• Mentor and guide junior regulatory staff; champion regulatory excellence and continuous improvement initiatives across processes systems and tools.
• Stay ahead of competitor landscape and regulatory trends in China providing insights that inform strategic decision-making.
• Maintain close collaboration with global key stakeholders such as GRL GDL and PSL to provide timely China regulatory input and ensure alignment between local strategy and global development plans.

Qualifications and Skills

• Bachelors degree or higher in Pharmacy Life Sciences Medicine or a related scientific field; advanced degree (Masters or PhD) preferred.
• Minimum of 15 years of progressive experience in pharmaceutical regulatory affairs withat least 8 years focused on oncology drug development and registrationin China.
• Strong track record ofleading successful NDA/BLA submissions and managing NMPA review processes including responding to HA inquiries and participating in regulatory meetings.
• In-depth understanding ofChina drug registration regulations (NMPA) ICH guidelines and global regulatory standards.
• Demonstrated ability todevelop and execute innovative regulatory strategiesin complex fast-changing environments.
• Proven experience inleading cross-functional teamsand influencing outcomes without direct authority.
• Excellentwritten and verbal communication skills in English and Mandarin; ability to present complex regulatory concepts clearly and persuasively.
• Strategic thinker with strong problem-solving abilities attention to detail and a results-driven mindset.
• Highly adaptable proactive and capable of managing multiple priorities under tight timelines.

在吉利德我们致力于为所有人创造一个更健康的世界过往逾35年间我们在HIV病毒性肝炎COVID-19肿瘤等危及生命的疾病领域持续推动药物革新改善患者生活并在全球范围内提升药物可及未来我们将继续应对全球最具挑战的健康问题为实现这一使命需要我们同心协力坚定信念和不懈努力

每个你都将在我们探索和推动改变生命的科学创新进程中扮演至关重要的角色吉客是我们得以实现伟大愿景的重要伙伴我们期待充满热忱志存高远的你在这里创造真正的影响力

我们深信卓越的管理者才能赋能卓越的团队每一位吉利德领袖都致力于为吉客创造积极的工作体验无论你现在抑或有志向成为团队管理者都是塑造吉客文化的关键引擎让我们共同创造一个让每位吉客都能感受到包容持续成长和充分赋能的职场环境实现未来无限可能

加入吉利德科学携手突破不可能

Key Responsibilities

• Lead the development and implementation of comprehensive regulatory strategiesfor assigned products and programs in oncology and inflammation from pre-IND/IND NDA/BLA through approval and post-marketing phases ensuring alignment with global plans and local regulation requirements.
• Serve as theChina Affiliate Regulatory TA Leadfor complex or high-priority molecules indications or development programs providing strategic input to cross-functional teams including Clinical Development CMC Pharmacovigilance and Commercial.
• Drive end-to-endNDA/BLA submissions and regulatory approvals including leading cross-functional teams in dossier preparation responding to HA questions managing RTQ processes and supporting inspection readiness.
• Lead and manage all interactions with CDE/NMPA and other local health authorities including pre-IND pre-NDA major milestone meetings and ad hoc communications; act as the primary regulatory point of contact for regulatory authorities in China.
• Oversee timely and compliant submission ofclinical trial applications amendments annual reports and other trial-related documentsto ensure uninterrupted clinical development.
• Guide the preparation of key regulatory documents including briefing packages meeting requests responses to information requests and risk-benefit analyses.
• Proactively monitor and interpret evolvinglocal regulatory requirements guidance and policies and ensure rapid integration into China regulatory strategies; contribute to shaping new regulations through constructive engagement.
• Provide regulatory input intopromotional materials review and lifecycle planning ensuring compliance with approved labeling and local advertising regulations.
• Represent Regulatory Affairs incross-functional brand teams and internal governance committees contributing to product positioning and launch readiness.
• Mentor and guide junior regulatory staff; champion regulatory excellence and continuous improvement initiatives across processes systems and tools.
• Stay ahead of competitor landscape and regulatory trends in China providing insights that inform strategic decision-making.
• Maintain close collaboration with global key stakeholders such as GRL GDL and PSL to provide timely China regulatory input and ensure alignment between local strategy and global development plans.

Qualifications and Skills

• Bachelors degree or higher in Pharmacy Life Sciences Medicine or a related scientific field; advanced degree (Masters or PhD) preferred.
• Minimum of 15 years of progressive experience in pharmaceutical regulatory affairs withat least 8 years focused on oncology drug development and registrationin China.
• Strong track record ofleading successful NDA/BLA submissions and managing NMPA review processes including responding to HA inquiries and participating in regulatory meetings.
• In-depth understanding ofChina drug registration regulations (NMPA) ICH guidelines and global regulatory standards.
• Demonstrated ability todevelop and execute innovative regulatory strategiesin complex fast-changing environments.
• Proven experience inleading cross-functional teamsand influencing outcomes without direct authority.
• Excellentwritten and verbal communication skills in English and Mandarin; ability to present complex regulatory concepts clearly and persuasively.
• Strategic thinker with strong problem-solving abilities attention to detail and a results-driven mindset.
• Highly adaptable proactive and capable of managing multiple priorities under tight timelines.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.