Director, Regulatory Affairs

Описание вакансии

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 execution of China regulatory strategies for assigned early-phase assets and programs, from asset entry and development candidate selection through pre-IND/IND, first-in-human, proof-of-concept and dose-expansion stages.
• Provide early and proactive China regulatory input into global development plans, including target product profile, indication and population strategy, dose and regimen selection, biomarker strategy, endpoint selection, China enrollment approach, and the timing and design of China participation in global studies.
• Assess whether and how China can participate in global early-phase studies; identify China-specific regulatory considerations and develop practical mitigation plans to enable timely inclusion of China.
• Lead regulatory pathway assessments for innovative modalities, novel mechanisms, combination regimens and complex clinical development programs, translating evolving China requirements into clear strategic options and recommendations.
• Plan and lead interactions with CDE/NMPA and other relevant health authorities, including pre-IND and other milestone consultations; develop meeting objectives, briefing packages, question strategy and follow-up actions.
• Lead or oversee high-quality and timely IND/CTA submissions, amendments, safety-related submissions, annual reports and other clinical trial regulatory activities, ensuring compliance and continuity of development.
• Identify regulatory risks, evidence gaps, dependencies and decision points early; develop scenario-based options, escalation recommendations and actionable risk mitigation plans.
• Monitor and interpret China regulations, technical guidelines, review practices and policy developments relevant to early development, and rapidly integrate insights into asset strategies and portfolio planning.
• Build strong partnerships with Global Regulatory Leaders, Global Development Leaders, Product Strategy Leads and China cross-functional stakeholders to ensure alignment between local strategy, global development plans and portfolio priorities.
• Mentor and coach regulatory colleagues, strengthen early-phase regulatory capability within the China RA team, and contribute to regulatory excellence and continuous improvement.

Qualifications and Skills

• Bachelor’s degree or higher in Pharmacy, Life Sciences, Medicine or a related scientific field; an advanced degree is preferred.
• Director level: typically 12+ years of progressive pharmaceutical regulatory affairs or drug development experience. Associate Director level: typically 10+ years. Level will be determined based on the depth, breadth and impact of relevant experience.
• Substantial hands-on experience in early-phase drug development and China regulatory strategy, including pre-IND/IND, first-in-human and proof-of-concept programs; experience in oncology and/or inflammation is strongly preferred.
• Demonstrated ability to shape clinical development strategy, not only manage submissions, and to translate scientific, clinical and regulatory considerations into clear development options and recommendations.
• Experience leading interactions with CDE/NMPA and preparing high-quality briefing packages, meeting questions, IND/CTA dossiers and responses to health authority inquiries.
• Strong understanding of China drug registration regulations, ICH guidelines and global drug development principles; familiarity with innovative modalities, combination strategies or biomarker-driven development is an advantage.
• Proven ability to exercise sound judgment under uncertainty, lead cross-functional discussions, influence global stakeholders and communicate a compelling China perspective in governance and decision-making forums.
• Excellent written and verbal communication skills in English and Mandarin. Strategic, curious, collaborative and results-oriented, with strong problem-solving skills and the ability to manage multiple priorities in a fast-moving environment.

Position Summary

The Regulatory Affairs Director / Associate Director is a strategic role responsible for shaping and executing China regulatory strategies for early-phase development programs, with a primary focus on oncology and inflammation. The position will provide China regulatory leadership from asset entry and development candidate selection through pre-IND/IND, first-in-human, proof-of-concept and dose-expansion stages, ensuring that China requirements and opportunities are incorporated early into global development plans. The incumbent will partner closely with Global Regulatory, Clinical Development, Clinical Operations, CMC, Nonclinical, Biostatistics, Pharmacovigilance and other functions to enable scientifically robust, operationally feasible and globally aligned development strategies, while establishing a clear pathway toward later-stage development and registration in China.

Key Responsibilities

• Lead the development and execution of China regulatory strategies for assigned early-phase assets and programs, from asset entry and development candidate selection through pre-IND/IND, first-in-human, proof-of-concept and dose-expansion stages.
• Provide early and proactive China regulatory input into global development plans, including target product profile, indication and population strategy, dose and regimen selection, biomarker strategy, endpoint selection, China enrollment approach, and the timing and design of China participation in global studies.
• Assess whether and how China can participate in global early-phase studies; identify China-specific regulatory considerations and develop practical mitigation plans to enable timely inclusion of China.
• Lead regulatory pathway assessments for innovative modalities, novel mechanisms, combination regimens and complex clinical development programs, translating evolving China requirements into clear strategic options and recommendations.
• Plan and lead interactions with CDE/NMPA and other relevant health authorities, including pre-IND and other milestone consultations; develop meeting objectives, briefing packages, question strategy and follow-up actions.
• Lead or oversee high-quality and timely IND/CTA submissions, amendments, safety-related submissions, annual reports and other clinical trial regulatory activities, ensuring compliance and continuity of development.
• Identify regulatory risks, evidence gaps, dependencies and decision points early; develop scenario-based options, escalation recommendations and actionable risk mitigation plans.
• Monitor and interpret China regulations, technical guidelines, review practices and policy developments relevant to early development, and rapidly integrate insights into asset strategies and portfolio planning.
• Build strong partnerships with Global Regulatory Leaders, Global Development Leaders, Product Strategy Leads and China cross-functional stakeholders to ensure alignment between local strategy, global development plans and portfolio priorities.
• Mentor and coach regulatory colleagues, strengthen early-phase regulatory capability within the China RA team, and contribute to regulatory excellence and continuous improvement.

Qualifications and Skills

• Bachelor’s degree or higher in Pharmacy, Life Sciences, Medicine or a related scientific field; an advanced degree is preferred.
• Director level: typically 12+ years of progressive pharmaceutical regulatory affairs or drug development experience. Associate Director level: typically 10+ years. Level will be determined based on the depth, breadth and impact of relevant experience.
• Substantial hands-on experience in early-phase drug development and China regulatory strategy, including pre-IND/IND, first-in-human and proof-of-concept programs; experience in oncology and/or inflammation is strongly preferred.
• Demonstrated ability to shape clinical development strategy, not only manage submissions, and to translate scientific, clinical and regulatory considerations into clear development options and recommendations.
• Experience leading interactions with CDE/NMPA and preparing high-quality briefing packages, meeting questions, IND/CTA dossiers and responses to health authority inquiries.
• Strong understanding of China drug registration regulations, ICH guidelines and global drug development principles; familiarity with innovative modalities, combination strategies or biomarker-driven development is an advantage.
• Proven ability to exercise sound judgment under uncertainty, lead cross-functional discussions, influence global stakeholders and communicate a compelling China perspective in governance and decision-making forums.
• Excellent written and verbal communication skills in English and Mandarin. Strategic, curious, collaborative and results-oriented, with strong problem-solving skills and the ability to manage multiple priorities in a fast-moving environment.

职位概述

注册事务总监/副总监是中国注册事务团队中的战略性岗位，重点负责公司早期临床开发项目在中国的注册策略制定与执行，主要聚焦肿瘤和炎症治疗领域。该职位将从项目引入及候选化合物确定阶段开始，持续为pre-IND/IND、首次人体试验（FIH）、概念验证（PoC）及剂量扩展阶段提供中国注册策略，推动在全球开发计划形成早期即充分纳入中国法规要求、开发机会和实施可行性。候选人需与全球注册、临床开发、临床运营、CMC、非临床、生物统计和药物安全等团队紧密合作，制定科学严谨、实施可行且与全球高度协同的开发策略，并为后续关键性临床开发及中国注册申报建立清晰路径。

主要职责

• 主导所负责早期项目在中国的注册策略制定与执行，覆盖项目引入、候选化合物确定、pre-IND/IND、FIH、PoC及剂量扩展等阶段。
• 前瞻性地为全球开发计划提供中国注册策略见解，包括目标产品特征、适应症与目标人群、剂量与给药方案、生物标志物策略、终点选择、中国入组策略，以及中国参与全球研究的时机和设计。
• 评估中国是否以及如何参与全球早期临床研究，识别中国特有的法规、临床及运营要求，并制定切实可行的解决方案，推动中国及时纳入全球开发。
• 针对创新治疗方式、新作用机制、联合治疗及复杂临床开发项目开展注册路径评估，将持续变化的中国法规要求转化为清晰的策略选项和建议。
• 作为早期项目的中国注册项目负责人，参与跨职能开发团队及决策机制，代表中国本地视角并通过专业影响力推动全球决策。
• 规划并主导与CDE/NMPA及其他相关监管机构的沟通，包括pre-IND及其他关键里程碑会议；负责会议目标、沟通问题策略、简报资料及会后行动的制定与落实。
• 从注册策略角度审阅早期临床开发核心文件，包括临床试验方案、研究者手册、知情同意相关注册内容、临床及非临床总结、CMC资料和监管问询回复。
• 尽早识别注册风险、证据缺口、关键依赖及决策节点，形成情景化策略选项、升级建议和可执行的风险缓解计划。
• 持续跟踪并解读与早期开发相关的中国法规、技术指导原则、审评实践及政策趋势，快速将洞察融入具体项目策略和管线规划。
• 与总部产品注册负责人、开发负责人、产品策略负责人及中国跨职能团队建立紧密合作，确保中国策略与全球开发计划及管线优先级一致。
• 支持项目从早期向后期开发的有效衔接，清晰记录关键注册决策、监管承诺、风险及证据要求；同时指导和培养注册同事，提升中国RA团队的早期开发注册能力。

任职资格与能力要求

• 药学、生命科学、医学或相关专业本科及以上学历；硕士或博士学位优先。
• 总监级别：通常具备12年以上制药行业注册事务或药物开发相关经验；副总监级别：通常具备10年以上相关经验。最终职级将根据候选人相关经验的深度、广度和影响力综合确定。
• 具备扎实的早期药物开发及中国注册策略实战经验，包括pre-IND/IND、FIH和PoC项目；具有肿瘤和/或炎症领域经验者优先。
• 能够从临床开发策略层面发挥作用，而不仅限于申报执行；能够整合科学、临床及法规因素，形成清晰的开发策略选项和建议。
• 具有主导CDE/NMPA沟通的经验，能够高质量完成会议简报、沟通问题、IND/CTA申报资料及监管问询回复。
• 深入理解中国药品注册法规、ICH指导原则及全球药物开发基本原则；具备创新治疗方式、联合治疗或生物标志物驱动开发经验者优先。
• 能够在证据不完整或持续变化的情况下进行专业判断，识别适宜的注册路径并制定风险缓解策略。
• 具备领导跨职能讨论、影响全球利益相关方并在治理决策机制中清晰表达中国观点的能力。
• 中英文书面及口头沟通能力优秀；具备战略思维、协作精神和结果导向，拥有出色的问题解决能力，并能在快速变化的环境中有效管理多项优先任务。

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.

Job Title (Translated)

注册事务总监

Job Description (Translated)

Position SummaryThe Regulatory Affairs Director / Associate Director is a strategic role responsible for shaping and executing China regulatory strategies for early-phase development programs, with a primary focus on oncology and inflammation. The position will provide China regulatory leadership from asset entry and development candidate selection through pre-IND/IND, first-in-human, proof-of-concept and dose-expansion stages, ensuring that China requirements and opportunities are incorporated early into global development plans. The incumbent will partner closely with Global Regulatory, Clinical Development, Clinical Operations, CMC, Nonclinical, Biostatistics, Pharmacovigilance and other functions to enable scientifically robust, operationally feasible and globally aligned development strategies, while establishing a clear pathway toward later-stage development and registration in China. Key ResponsibilitiesLead the development and execution of China regulatory strategies for assigned early-phase assets and programs, from asset entry and development candidate selection through pre-IND/IND, first-in-human, proof-of-concept and dose-expansion stages. Provide early and proactive China regulatory input into global development plans, including target product profile, indication and population strategy, dose and regimen selection, biomarker strategy, endpoint selection, China enrollment approach, and the timing and design of China participation in global studies. Assess whether and how China can participate in global early-phase studies; identify China-specific regulatory considerations and develop practical mitigation plans to enable timely inclusion of China. Lead regulatory pathway assessments for innovative modalities, novel mechanisms, combination regimens and complex clinical development programs, translating evolving China requirements into clear strategic options and recommendations. Plan and lead interactions with CDE/NMPA and other relevant health authorities, including pre-IND and other milestone consultations; develop meeting objectives, briefing packages, question strategy and follow-up actions. Lead or oversee high-quality and timely IND/CTA submissions, amendments, safety-related submissions, annual reports and other clinical trial regulatory activities, ensuring compliance and continuity of development. Identify regulatory risks, evidence gaps, dependencies and decision points early; develop scenario-based options, escalation recommendations and actionable risk mitigation plans. Monitor and interpret China regulations, technical guidelines, review practices and policy developments relevant to early development, and rapidly integrate insights into asset strategies and portfolio planning. Build strong partnerships with Global Regulatory Leaders, Global Development Leaders, Product Strategy Leads and China cross-functional stakeholders to ensure alignment between local strategy, global development plans and portfolio priorities. Mentor and coach regulatory colleagues, strengthen early-phase regulatory capability within the China RA team, and contribute to regulatory excellence and continuous improvement. Qualifications and Skills Bachelor’s degree or higher in Pharmacy, Life Sciences, Medicine or a related scientific field; an advanced degree is preferred. Director level: typically 12+ years of progressive pharmaceutical regulatory affairs or drug development experience. Associate Director level: typically 10+ years. Level will be determined based on the depth, breadth and impact of relevant experience. Substantial hands-on experience in early-phase drug development and China regulatory strategy, including pre-IND/IND, first-in-human and proof-of-concept programs; experience in oncology and/or inflammation is strongly preferred. Demonstrated ability to shape clinical development strategy, not only manage submissions, and to translate scientific, clinical and regulatory considerations into clear development options and recommendations. Experience leading interactions with CDE/NMPA and preparing high-quality briefing packages, meeting questions, IND/CTA dossiers and responses to health authority inquiries. Strong understanding of China drug registration regulations, ICH guidelines and global drug development principles; familiarity with innovative modalities, combination strategies or biomarker-driven development is an advantage. Proven ability to exercise sound judgment under uncertainty, lead cross-functional discussions, influence global stakeholders and communicate a compelling China perspective in governance and decision-making forums. Excellent written and verbal communication skills in English and Mandarin. Strategic, curious, collaborative and results-oriented, with strong problem-solving skills and the ability to manage multiple priorities in a fast-moving environment. 职位概述注册事务总监/副总监是中国注册事务团队中的战略性岗位，重点负责公司早期临床开发项目在中国的注册策略制定与执行，主要聚焦肿瘤和炎症治疗领域。该职位将从项目引入及候选化合物确定阶段开始，持续为pre-IND/IND、首次人体试验（FIH）、概念验证（PoC）及剂量扩展阶段提供中国注册策略，推动在全球开发计划形成早期即充分纳入中国法规要求、开发机会和实施可行性。候选人需与全球注册、临床开发、临床运营、CMC、非临床、生物统计和药物安全等团队紧密合作，制定科学严谨、实施可行且与全球高度协同的开发策略，并为后续关键性临床开发及中国注册申报建立清晰路径。 主要职责主导所负责早期项目在中国的注册策略制定与执行，覆盖项目引入、候选化合物确定、pre-IND/IND、FIH、PoC及剂量扩展等阶段。 前瞻性地为全球开发计划提供中国注册策略见解，包括目标产品特征、适应症与目标人群、剂量与给药方案、生物标志物策略、终点选择、中国入组策略，以及中国参与全球研究的时机和设计。 评估中国是否以及如何参与全球早期临床研究，识别中国特有的法规、临床及运营要求，并制定切实可行的解决方案，推动中国及时纳入全球开发。 针对创新治疗方式、新作用机制、联合治疗及复杂临床开发项目开展注册路径评估，将持续变化的中国法规要求转化为清晰的策略选项和建议。 作为早期项目的中国注册项目负责人，参与跨职能开发团队及决策机制，代表中国本地视角并通过专业影响力推动全球决策。 规划并主导与CDE/NMPA及其他相关监管机构的沟通，包括pre-IND及其他关键里程碑会议；负责会议目标、沟通问题策略、简报资料及会后行动的制定与落实。 从注册策略角度审阅早期临床开发核心文件，包括临床试验方案、研究者手册、知情同意相关注册内容、临床及非临床总结、CMC资料和监管问询回复。 尽早识别注册风险、证据缺口、关键依赖及决策节点，形成情景化策略选项、升级建议和可执行的风险缓解计划。 持续跟踪并解读与早期开发相关的中国法规、技术指导原则、审评实践及政策趋势，快速将洞察融入具体项目策略和管线规划。 与总部产品注册负责人、开发负责人、产品策略负责人及中国跨职能团队建立紧密合作，确保中国策略与全球开发计划及管线优先级一致。 支持项目从早期向后期开发的有效衔接，清晰记录关键注册决策、监管承诺、风险及证据要求；同时指导和培养注册同事，提升中国RA团队的早期开发注册能力。 任职资格与能力要求药学、生命科学、医学或相关专业本科及以上学历；硕士或博士学位优先。 总监级别：通常具备12年以上制药行业注册事务或药物开发相关经验；副总监级别：通常具备10年以上相关经验。最终职级将根据候选人相关经验的深度、广度和影响力综合确定。 具备扎实的早期药物开发及中国注册策略实战经验，包括pre-IND/IND、FIH和PoC项目；具有肿瘤和/或炎症领域经验者优先。 能够从临床开发策略层面发挥作用，而不仅限于申报执行；能够整合科学、临床及法规因素，形成清晰的开发策略选项和建议。 具有主导CDE/NMPA沟通的经验，能够高质量完成会议简报、沟通问题、IND/CTA申报资料及监管问询回复。 深入理解中国药品注册法规、ICH指导原则及全球药物开发基本原则；具备创新治疗方式、联合治疗或生物标志物驱动开发经验者优先。 能够在证据不完整或持续变化的情况下进行专业判断，识别适宜的注册路径并制定风险缓解策略。 具备领导跨职能讨论、影响全球利益相关方并在治理决策机制中清晰表达中国观点的能力。 中英文书面及口头沟通能力优秀；具备战略思维、协作精神和结果导向，拥有出色的问题解决能力，并能在快速变化的环境中有效管理多项优先任务。