默克生命科学
Head of Regulatory Management China
Head of Regulatory Management China
发布于 2 天前中层管理(经理/总监)
上海市
专家级经验
全职员工
仅现场办公
本科
NMPA
Compliance
Stakeholder Management
Risk Assessment
Process Optimization
Regulatory Management
AI 估算 · 40k–60k
作为跨国巨头中国区法规负责人，薪资有竞争力，综合行业和城市水平估算。
职位详情
关于这个职位
该职位是默克生命科学中国区法规管理负责人，负责制定法规策略、管理注册事务、维护与政府机构的关系，并带领团队确保业务合规
适合拥有10年以上制药/生命科学行业经验、熟悉NMPA法规的专业人士
最低要求
Degree in pharmaceutical, life sciences, or related area.
Fluent in Chinese native & English (verbal and written) is required.
Experience of minimum 10 years in Pharma and Life Sciences industry, extensive knowledge in life science products.
Broad and extensive knowledge of Biopharm, Pharm & Food materials, MD & IVD, regulatory and quality requirements. Extensive regulatory and quality knowledge of China laws and regulations of NMPA. Familiar with US and European regulations in above mentioned areas.
Close working relationships with authorities (NMPA, provincial MPA, ChP Committee, NIFDC, NHC, CFDS, etc.)
Customer centricity.
Experience working in a global, matrix environment.
People management experience to lead a team in complex and fasting changing environment.
Excellent interpersonal, presentation, listening and communication skills that will develop long term internal and external relationships at all levels.
Strong organizational and time management skills.
Ability to manage multiple priorities and deliver accurate outcomes.
Ability to indirectly influence other organizations and cultures.
Ability to train and educate others.
Effective management by influence.
Experience in thought leadership.
Ability to work in multi-cultural teams.
Proficient in MS Office Software (Word, Excel, PowerPoint, Project).
Able to travel.
工作职责
Strategy:**
Drive thought leadership initiatives and build up relationship and advocacy with local authorities and industry/trade associations.
Monitor and report on changes of relevant regulatory and compliance environment.
Effective coordination of strategic activities with subject matter experts, local regulatory bodies and industry associations.
Manage and support businesses on evolving requirements.
Drive implementation of policies and instructions through monitoring, self-assessments and periodic audits.
Provide guidance and coordinate regulatory activities such as certification/notification.
Training and support to internal stakeholders, external customers and relevant regulatory bodies.
Closely work with global/regional regulatory surveillance & advocacy team.
Drive, manage and coordinate registration/notification/listing activities.
Ensure relevant changes to product regulatory status are properly notified.
Local regulatory compliance as it relates to new operation setup, business opportunities and product launches.
Drive and develop digitalization strategy and automation tools.
Proactively contribute to APAC regulatory working group.
Define and clarify roles & responsibilities of Regulatory Management and other internal functions.
Operation Excellence:**
Perform periodical internal audit, identify compliance process gaps.
Provide guidance in risk assessment, identify compliance impact and provide recommendations.
Periodical compliance risk review and reporting.
Ensure set up KPIs in alignment with business requirement.
Implement global regulatory management policy and best practice procedures.
Process optimization:**
Periodical review of Regulatory processes, ensure operational excellence in import/export and domestic compliance.
Develop lean process with continuous improvement and measurement.
Including Regulatory internal processes and processes with other relevant functions.
Identify opportunities for process efficiency and effectiveness through automation or process improvement.
Build for tomorrow:**
Initiate and manage Regulatory strategic projects in align with business strategy.
Establish overview of all Regulatory relevant projects, define RACI and actions.
Capability development: develop comprehensive capability development strategy and training program.
AI 洞察
优缺点分析
优点
- 默克作为全球生命科学巨头，平台大、资源丰富，能接触到最前沿的法规动态
- 职位影响力高，直接参与中国法规环境建设，与政府高层互动
- 薪资福利优厚，外企文化成熟，注重员工发展
- 法规环境复杂多变，需要持续学习和快速适应
- 跨部门协调和影响力管理难度大，需处理多方利益
- 适合在制药/生命科学领域有10年以上法规经验，渴望发挥领导力、推动行业变革的专业人士
缺点 / 挑战
- 工作压力不小，涉及多个项目同时推进，需较强的抗压能力
角色解读
- 可晋升为亚太区或全球法规负责人，扩大管理范围和影响力
- 深化在生命科学领域的法规 expertise，成为行业思想领袖
- 向更综合的管理岗位发展，如业务运营或战略规划
- 制定中国区生命科学业务法规策略，主导与政府、行业协会的沟通与 advocacy
- 管理产品注册、许可申请，确保持续合规并支持业务发展
- 领导法规管理团队，优化内部流程，推动数字化转型提升效率
- 跟踪法规变化，进行风险评估，为业务决策提供合规建议
- 深厚的制药/生命科学行业知识，熟悉NMPA及国际法规
- 出色的人际沟通与影响力，能与政府机构和内部跨部门协作
- 团队管理经验，能在复杂矩阵环境中带领团队
- 战略思维与项目管理能力，能推动 Thought Leadership 项目
申请策略
- 深入了解默克在中国生命科学领域的业务重点，面试中展现对行业的洞察
- 提前准备1-2个自己主导的法规策略案例，体现变革领导力
- 突出与NMPA等政府机构的合作成果，如成功注册案例、政策倡导经历
- 强调团队管理经验，包括团队规模、培养下属的成果
- 展示战略项目经验，如推动流程优化或数字化转型的实例
- 提及跨文化工作经历，尤其是与全球团队协作的案例
- 如果对数字工具不熟悉，提前学习自动化流程或数据管理工具
- 加强英语沟通能力，尤其是商务演讲和报告撰写
面试指南
- 使用STAR法则（情境、任务、行动、结果）结构化回答
- 突出关键影响力、战略思考和团队协作
- 强调数据驱动决策和持续改进的思维
- 请分享一次您成功影响政府法规政策的经历
- 您如何管理一个多项目并行且法规要求不断变化的团队？
- 面对新的法规出台，您如何评估业务影响并制定应对策略？
- 请描述您在跨文化矩阵环境中推动一项合规改进的过程
- 您如何看待生命科学行业数字化对法规管理的影响？
匹配度报告
72
综合匹配度
稳定外企高管、薪酬优厚、发展空间好，但现场办公和出差较多。
适合人群
该职位最适合注重薪酬福利和职业发展，且能在生命科学法规领域实现个人价值、不介意现场办公的资深专业人士。
最强匹配
薪资福利匹配
最弱匹配
工作生活匹配
薪资福利85
成长发展75
工作生活50
使命价值80
薪资福利匹配
85较高
该职位薪资面议，但跨国巨头高层职位通常提供极具竞争力的薪酬和福利，包括年终奖、补充保险等，满足补偿性动机程度高。
薪资信号面议 (40K-60K/月)
成长发展匹配
75中等
职位强调战略项目、能力发展和数字化转型，提供成长机会，但JD未明确晋升路径，发展性动机满足程度中等偏上。
技术前沿主流现代技术
技术栈Digitalization、Automation、Data Quality
成长机会capability development、training
业务类型profit_center
工作生活匹配
50较低
JD未提及弹性工作或远程办公，且高层管理职位通常需要现场办公和出差，生活化动机满足程度一般。
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）
使命价值匹配
80较高
生命科学行业关乎健康，默克使命是改善人类生活，职位能直接推动法规进步和社会健康，意义感较强。
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enrich people's lives、Spark Discovery、Elevate Humanity
创新程度积极采用新技术
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