默沙东
Manager, CMC
Manager, CMC
发布于 大约 3 小时前中层管理(经理/总监)
上海市 / 北京市
中级经验
全职员工
仅现场办公
本科
医疗、制药与临床研究
CMC
Leadership
Regulatory Affairs
Ich Guidelines
AI 估算 · 30k–50k
跨国药企经理级，CMC监管专业经验稀缺，薪资具有竞争力。
职位详情
关于这个职位
作为默沙东CMC监管经理，您将负责制定和执行CMC政策策略，与药监机构、行业协会等外部利益相关者沟通，确保中国区与全球团队的CMC法规合规
同时领导CMC申报、沟通及产品开发中的监管支持工作，是连接研发与注册的关键角色
最低要求
BS, MS, or PhD degree in chemistry, biology, or related scientific disciplines; an advanced degree is preferred.
Expertise in CMC areas such as chemistry, formulation, and analytical, 3~5 years of R&D; and/or regulatory experience.
Knowledge of CMC regulatory requirements and ICH guidelines.
Good oral and written communication skills in both English and Chinese;
Proactive and teamwork spirits
工作职责
Lead Regulatory CMC Policy & Intelligence efforts to effectively navigate the regulatory landscape, advocate for CMC policies, and contribute to achieving strategic policy objectives.
Develop and implement CMC policy strategies that align with regulatory requirements and organizational goals.
Develop clear and persuasive CMC regulatory positions on relevant issues in collaboration with global, local, and external stakeholders, including industry associations, etc.
Engage proactively with the Health Authorities (HA), industry associations, advocacy groups, and other external partners to establish the company’s voice and leadership in task forces, meetings, and advocacy efforts. Establish and maintain a robust internal policy network to drive coordinated influence strategies.
Ensure organizational awareness, alignment, and implementation of relevant CMC policy requirements between the global and China teams.
Closely monitor, manage, triage, and archive regulatory CMC requirements and guidance documents. Lead the preparation of insightful comments on draft regulations, guidance, and other policy documents.
Take the CMC lead for products under clinical development and for marketed drug products. Coordinate various aspects of CMC regulatory activities with internal and external stakeholders. Act as the primary internal and external representative for CMC issues.
Provide CMC expertise to support drug development at various stages, including clinical trial application, NDA, and post-approval variations
Lead the communication with HQ CMC and China RA teams to ensure high-quality CMC submissions in compliance with China regulations and guidelines
Act as a primary contact for CMC query response, lead and coordinate the response process between China and HQ teams, and interact with the agency for project-related CMC issues
Work with regulatory colleagues on specification, quality control testing, and inspection for specific products; provide technical input and facilitate the discussion between China and HQ teams
Participate in China project development teams to provide CMC regulatory assessment and strategy by working with regulatory and project leads
Develop a network with pharmaceutical industrial associations and participate in CMC initiatives and task forces
AI 洞察
优缺点分析
优点
- 默沙东作为顶级药企，提供全球化平台和资源，参与制定行业标准
- CMC监管方向专业壁垒高，长期职业发展稳定且富有影响力
- 跨部门协作和外部沟通经验能快速提升综合能力
- 监管政策动态变化快，需要持续学习并适应新法规
- 协调全球与本地团队可能涉及时差和文化差异，沟通复杂度高
- 适合具有深厚CMC技术背景且希望向监管和政策方向转型的资深专业人士，乐于沟通、影响决策并推动合规
缺点 / 挑战
- 作为管理层，需要同时处理战略和细节工作，压力较大
角色解读
- 向高级CMC总监或全球监管职位发展，负责更大区域或产品组合
- 可转向更广泛的监管事务或药物开发领导岗位
- 在行业政策影响力方面成为专家，担任行业协会要职
- 制定并推动CMC监管政策战略，影响行业法规走向
- 与药监机构、行业协会等建立沟通网络，代表公司发声
- 协调全球与中国团队，确保CMC申报合规高效
- 为产品从临床到上市各阶段提供CMC专业支持
- 精通CMC领域知识（化学、制剂、分析）及ICH指南
- 出色的中英文口头与书面沟通能力，能跨文化协作
- 具备政策分析和战略制定能力，能影响外部利益相关者
- 主动性强，善于团队合作和项目管理
申请策略
- 了解默沙东的产品线和CMC策略，面试中展现对公司的兴趣和对行业的洞察
- 突出CMC相关项目经验，特别是涉及监管申报和药监沟通的案例
- 展示政策分析成果，如参与起草法规评论或行业协会工作
- 强调中英文双语能力和跨文化协作经历
- 补充ICH指南和最新中国药品注册法规知识
- 提升数据分析和政策研究能力，如学习如何撰写监管反馈
面试指南
- 使用STAR原则：情境、任务、行动、结果，突出沟通和策略性
- 强调合规与商业目标的平衡，展示专业判断力
- 展现主动性，如提前预警法规风险并提出解决方案
- 请描述一次您成功协调跨区域CMC申报的经历
- 如何跟踪和影响监管政策变化？请举例
- 当中国法规与国际指南冲突时，您如何制定CMC策略？
- 您如何与药监机构建立并维持良好关系？
- 复习ICH Q系列指南及中国NMPA最新法规
匹配度报告
71
综合匹配度
跨国药企管理岗，CMC监管专家，发展前景好但工作生活平衡一般。
适合人群
最适合追求专业成长、政策影响力和稳定职业发展的求职者。
最强匹配
成长发展匹配
最弱匹配
工作生活匹配
薪资福利70
成长发展85
工作生活50
使命价值80
薪资福利匹配
70中等
薪资未明确披露，但作为跨国药企经理级，通常提供有竞争力的薪酬福利体系，补偿性动机满足度中等偏上。
薪资信号未披露（AI估算：30K-50K/月）
成长发展匹配
85较高
该职位提供政策制定、外部沟通等复合发展机会，能接触全球监管前沿，成长空间大，发展性动机满足度较高。
技术前沿传统/成熟技术
技术栈CMC、Regulatory、ICH Guidelines、Chemistry、Formulation、Analytical
业务类型ambiguous
工作生活匹配
50较低
未提及远程或弹性工作，多城市办公可能涉及通勤，生活化动机满足度一般。
工作模式仅现场办公
办公地点市区核心地段
加班情况未提及（无法判断）
使命价值匹配
80较高
制药监管工作直接保障药品安全与可及性，具有正向社会影响力，意义感动机满足度较高。
行业发展稳定成熟行业
社会影响正向社会影响力较高
创新程度稳健跟随主流
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