强生
Director, China RA TA Leader-Immunology
Director, China RA TA Leader-Immunology
发布于 5 小时前中层管理(经理/总监)
全职员工仅现场办公药品注册
药品注册
Ind/Nda申报
免疫治疗
医学写作
合规风险管理
团队管理
战略规划
生命周期管理
跨部门协作
值不值得投
81综合评分
综合评分 81
顶尖外企免疫治疗监管高管，战略发展空间大，使命驱动，兼顾灵活工时与高管责任
从薪资福利、成长发展、工作生活和使命价值四个维度综合评估，方便横向比较。
薪资怎么样
10.0万
比药品注册中位数高
发布情况
新岗位 · 今天发布
公司情况
这家公司招聘很活跃
约 250 个在招
市场机会
选择适中
北京 · 药品注册 · 21 个在招
职位详情
关于这个职位
负责强生免疫治疗产品组合在中国的全流程监管策略制定与执行，带领团队对接NMPA/CDE等监管机构，规划IND/NDA申报路径及标签策略
协调跨部门资源，应对监管问询与检查，支持并购交易中的监管尽职调查，确保产品合规上市并最大化患者可及性与商业价值
最低要求
化学、药剂学、生物学或相关生命科学领域的高级学位
拥有超过12年的监管事务经验，其中包括在跨国制药公司担任管理职务的至少5年
具备生物学背景者优先
具有直接或矩阵式人员管理经验者优先
工作职责
Own the end-to-end China regulatory strategy for the entire Immunology portfolio and drive all regulatory activities. Set the overarching regulatory roadmap aligned with global R&D; and commercial business priorities, with full accountability for shaping the regulatory direction of multiple assets across the immunology portfolio.
Build robust China Immunology TA regulatory capabilities and regulatory insights. Proactively monitor changes to the regulatory environment and industry landscape, identify strategic opportunities, guide the team to deliver technical input, translate expert recommendations into actionable regulatory strategies, and drive the implementation.
Lead the team to strategically define comprehensive regulatory pathways and continuously pursue innovative regulatory approaches (e.g., priority review, Breakthrough Therapy, rare disease / orphan designation, pilot program, etc).
Facilitate HA meetings (e.g., NMPA pre-IND and pre-NDA consultation meetings) supported by team members with well-prepared pre-meeting strategy and targeted communication plans. On one hand, coordinate internal communication and resources to achieve defined meeting objectives, secure favorable regulatory feedback for asset development. On the other hand, execute post-meeting action plans, maintain ongoing follow-up with health authorities, and deliver on meeting outcomes.
Guide team to evaluate target submission and approval timelines, POS, and change management based on R&D; and business strategy requirements and ensure timely alignment with key stakeholders. Lead submission timelines and cadence planning, identify critical-path items and bottlenecks, mobilize internal and external resources to deliver IND/NDA/Variation and other submission milestones, and provide timely updates to stakeholders.
Drive the development of a comprehensive labeling strategy with team members. Strategically design label claims and supporting evidence packages aligned with clinical data, scientific rationale and company positioning. Lead cross-functionally aligned HA negotiations to secure a label that maximizes patient access and product therapeutic value.
Lead the team to anticipate HAQs proactively, build evidence matrix and define optimized response strategy. Lead cross-functional teams to deliver robust, consistent responses to verbal and written HA queries to protect regulatory submissions.
Partner with CMCRA and CMC teams (e.g., DPDS, Supply Chain, Quality) to co-develop the China CMC regulatory strategy in Immunology RA, identify CMC-related risks and define mitigation plans. Integrate the CMC strategy into the overall regulatory strategy to secure regulatory approvals for Immunology TA.
Regulatory Leadership: Strategic Regulatory Inputs & Cross-Functional partnership
Build and lead the RA team to serve as the regulatory representative in Global Regulatory Team (GRT) meeting, Project Team (PT) meeting and other project forums, providing regulatory perspectives to align cross-functional objectives and unblock issues. Ensure close alignment with Global Regulatory Affairs (GRA) on regulatory strategy and with Project Teams to maximize development, patient benefit and commercial value.
Partner with R&D;, Commercial, Quality, Supply Chain and Pharmacovigilance to ensure consistent local, regional and global communication and execution. Act as a regulatory subject-matter expert embedded in cross-functional teams to provide regulatory input and enable collective decision-making.
Maintain clear escalation processes to ensure significant regulatory information received from Health Authorities is communicated and actioned appropriately.
Collaborate with cross-functional team to assess regulatory impacts of product launch and supply-chain changes and provide regulatory constraints and expert recommendations.
Evaluate the impacts of regulatory changes and emerging practices on Immunology TA.
External Engagement & Industry Interaction
Maintain professional engagement with CDE/NMPA and other Health Authorities and build robust partnerships to support Immunology portfolio development.
Monitor domestic regulatory and guideline updates relevant to Immunology and provide feedback on draft regulations, and gather industry intelligence.
Support GMP and GCP inspection readiness activities for Immunology projects.
Establish and nurture connections with Immunology external experts (KOLs) to track evolving regulatory practices and continuously elevate the company’s regulatory capabilities.
Team leadership & resourcing
Build a robust registration team and drive talent development
Team attendance management, performance management and annual budget planning.
Support headcount and budget planning accuracy of RA department
Oversee outsourced vendors; manage outsourcing project delivery and quality.
M&A;, BD and Incident Response
Support regulatory due diligence for mergers, acquisitions, licensing and BD transactions; identify transaction-related regulatory risks.
Lead cross-functional emergency response and remediation for regulatory inspections, significant safety or compliance events.
优先资格
具备生物学背景优先
具有直接或矩阵式人员管理经验优先
AI 洞察
优缺点分析
优点
- 顶尖跨国药企平台，提供充足的研发资源与全球化视野
- 聚焦前沿免疫治疗赛道，直接参与重磅药物从实验室到市场的核心环节
- 赋予高度战略自主权，可深度影响产品上市节奏与患者可及性
- 国内监管政策迭代迅速，需保持高强度持续学习与快速响应
- 矩阵式组织架构下，跨部门目标对齐与资源博弈难度较大
- 高管职责伴随高频差旅与跨时区会议，精力分配要求极高
- 具备深厚药政背景、擅长战略统筹与团队赋能，且能在不确定性环境中果断决策的资深专业人士
缺点 / 挑战
暂无明显挑战项
角色解读
- 可向全球监管事务副总裁或大中华区业务负责人方向晋升
- 横向拓展至商务拓展(BD)、产品开发或合规风控负责人
- 成为医药行业政策制定与产业标准的核心意见领袖
- 制定免疫治疗产品组合在中国的全流程监管策略与申报路线图
- 主导与NMPA/CDE等监管机构的高层沟通与咨询会议
- 领导RA团队完成IND/NDA申报、标签谈判及上市后变更管理
- 协调研发、商业、质量等跨部门资源，保障产品合规高效上市
- 精通中国药政法规体系及CDE最新指导原则
- 具备丰富的跨国药企监管事务实战与团队管理经验
- 卓越的跨文化沟通、谈判与矩阵式组织能力
- 敏锐的商业洞察力与复杂问题决策能力
申请策略
- 提前研究强生免疫管线布局及竞品申报进度，准备差异化策略思路
- 展现对监管合规底线与商业效率平衡的深刻理解
- 重点突出主导过的IND/NDA成功案例及获批周期缩短数据
- 量化团队规模、预算管理幅度及外包供应商管控成效
- 强调与监管机构高层互动的历史记录与政策反馈贡献
- 系统梳理CDE最新免疫治疗领域指导原则与医保准入逻辑
- 强化数据驱动的合规风险评估模型与商业决策分析能力
- 提升跨文化团队激励与虚拟项目管理技巧
面试指南
- 采用STAR法则结构化呈现案例，突出背景复杂性、个人决策节点与量化结果
- 构建“监测预警-影响评估-预案制定-跨部门演练-复盘迭代”的政策应对闭环
- 强调目标对齐机制、透明沟通渠道与授权赋能的团队管理逻辑
- 请分享一次你成功推动复杂监管审批或突破政策瓶颈的案例
- 面对NMPA突发政策调整，你的评估框架与应对预案是什么
- 如何管理跨时区、跨文化的虚拟团队并保证交付质量
- 当监管合规要求与商业上市时间表发生冲突时，你如何决策
- 梳理个人主导的核心项目时间轴、关键里程碑与最终获批文件
职位点评
薪资福利85
成长发展90
工作生活65
使命价值80
薪资福利
85较高
总监级职位提供极具竞争力的薪酬结构与完善福利体系，充分满足高收入与职业稳定性预期。
薪资信号未披露（AI估算：8.0千–12.0万/月）
成长发展
90较高
聚焦前沿免疫治疗与复杂药政环境，提供极高的专业纵深拓展与战略视野跃升空间。
技术前沿前沿/新兴技术
技术栈Regulatory Affairs、NMPA、IND/NDA、Immunology、CMC
成长机会drive talent development、Build robust registration team
业务类型profit_center
工作生活
65中等
提供灵活工时以适应全球会议，但高管职责伴随一定战略压力与差旅要求，整体平衡度中等。
工作模式未明确
办公地点未明确
加班情况未提及（无法判断）
工作生活平衡Ability to work flexible hours
使命价值
80较高
致力于突破复杂疾病治疗瓶颈，直接改善患者生活，使命感强烈且社会价值显著。
行业发展稳定成熟行业
社会影响正向社会影响力较高
使命信号build a world where complex diseases are prevented, treated, and cured、impact health for humanity
创新程度积极采用新技术
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