Regulatory Affairs Director

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
 

Key Responsibilities

• Lead the development and implementation of comprehensive regulatory strategies for 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 the China Affiliate Regulatory TA Lead for 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-end NDA/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 of clinical trial applications, amendments, annual reports, and other trial-related documents to 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 evolving local regulatory requirements, guidance, and policies, and ensure rapid integration into China regulatory strategies; contribute to shaping new regulations through constructive engagement.
• Provide regulatory input into promotional materials review and lifecycle planning, ensuring compliance with approved labeling and local advertising regulations.
• Represent Regulatory Affairs in cross-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

• Bachelor's degree or higher in Pharmacy, Life Sciences, Medicine, or a related scientific field; advanced degree (Master's or PhD) preferred.
• Minimum of 15 years of progressive experience in pharmaceutical regulatory affairs, with at least 8 years focused on oncology drug development and registration in China.
• Strong track record of leading successful NDA/BLA submissions and managing NMPA review processes, including responding to HA inquiries and participating in regulatory meetings.
• In-depth understanding of China drug registration regulations (NMPA), ICH guidelines, and global regulatory standards.
• Demonstrated ability to develop and execute innovative regulatory strategies in complex, fast-changing environments.
• Proven experience in leading cross-functional teams and influencing outcomes without direct authority.
• Excellent written 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。

Job Describtion Summary

The Regulatory Affairs Director is a key leadership role responsible for driving the end-to-end regulatory strategy and execution for Gilead's portfolio in China, with a primary focus on oncology and inflammation therapeutic areas. This position plays a pivotal role in shaping the regulatory pathway for both early- and late-stage assets, including clinical development support, NDA/BLA submission and approval, lifecycle management, and proactive engagement with CDE/NMPA and other local health authorities. The incumbent will serve as the China Regulatory TA lead, ensuring alignment between global regulatory strategy and local requirements, while accelerating patient access to innovative therapies.

Key Responsibilities

• Lead the development and implementation of comprehensive regulatory strategies for 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 the China Affiliate Regulatory TA Lead for 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-end NDA/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 of clinical trial applications, amendments, annual reports, and other trial-related documents to 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 evolving local regulatory requirements, guidance, and policies, and ensure rapid integration into China regulatory strategies; contribute to shaping new regulations through constructive engagement.
• Provide regulatory input into promotional materials review and lifecycle planning, ensuring compliance with approved labeling and local advertising regulations.
• Represent Regulatory Affairs in cross-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

• Bachelor's degree or higher in Pharmacy, Life Sciences, Medicine, or a related scientific field; advanced degree (Master's or PhD) preferred.
• Minimum of 15 years of progressive experience in pharmaceutical regulatory affairs, with at least 8 years focused on oncology drug development and registration in China.
• Strong track record of leading successful NDA/BLA submissions and managing NMPA review processes, including responding to HA inquiries and participating in regulatory meetings.
• In-depth understanding of China drug registration regulations (NMPA), ICH guidelines, and global regulatory standards.
• Demonstrated ability to develop and execute innovative regulatory strategies in complex, fast-changing environments.
• Proven experience in leading cross-functional teams and 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.

Please apply via the Internal Career Opportunities portal in Workday.