如约见 · 医疗健康 · 临床试验

中国技术法规(CMC)政策负责人

罗氏中国 · 北京 · 薪资面议 · 更新于 2026/10/18

任职要求

经验:1-0年

岗位描述

在罗氏,我们鼓励每位同事展现真实的自己;我们欣赏独特且出众的品质。罗氏的文化鼓励积极的表达、开放的对话和真诚的连结,在这里,你将因为做自己而被重视、接纳和尊重,并得到个人的提升和职业的发展。所有的这一切,都是为了更好地预防、阻止和治愈疾病,并确保医疗资源的可及性和可持续性。欢迎加入罗氏,一个重视每种声音的地方。 职位 The Opportunity Provide Leadership, oversight and execution of technical regulatory policy activities for the Roche Pharma Group relevant to China including the development of Roche policy positions on key topics relevant to Pharma Technical, and effective advocacy of such positions externally. Collaborate closely with the regulatory colleagues in China and globally to develop and execute the China regulatory policy roadmap Ensure alignment and stakeholder engagement within Pharma Technical Operations, Product Development, Pharma International, governmental affairs as well as external interest groups Key Responsibilities and Tasks Identify and enable regulatory policy activities in China such that Roche is globally recognized as an industry leader with health authority agencies and industry peer groups and that significant value is realized in facilitating pipeline development, marketing authorizations and excellence in manufacturing Build and maintain relationships based on trust and respect with key health authority professionals, relevant academic and opinion leaders and non-profit scientific associations Establish a strong partnership and networks with internal (i.e. Regulatory, Technical, Quality, Medical,, Gov. Affairs ) and external stakeholders Ensure the development, execution and communication of the China regulatory policy roadmap Lead strong cross-functional teams and regional/global regulatory communities of practice to drive policy change in China Represent Roche technical regulatory policy views in China (and beyond) during external stakeholder engagement Take leadership in local, regional and/or global associations (e.g. RDPAC, BIO, IFPMA…) and/or governmental organizations (e.g. APEC, ICH) in line with the Roche positions . Provide leadership and consultancy to Roche Pharma Division leaders on regulatory policy and strategy related topics affecting China Act as subject matter expert for key technical regulatory policy and strategy areas as assigned, lead the development of specified Global Regulatory Policy positions in close collaboration with SMEs. Build influencing and advocacy knowledge and capacity and empowers other colleagues to shape the regulatory environment Core Competencies, Skills Excellent collaboration skills Recognized expert in relevant CMC technical/regulatory area with established external credibility as thought leader Proven ability to build and maintain strong relationships with global health authorities Strong team player and communicator Creates an environment of strong team spirit, good communication, high motivation, inspire cross-functional project teams Excellent advocacy, communication and presentation skills Strategic thinking and analytical skills, ability to simplify complex topics and to pull it all together to strategic planning. Challenges the status quo to drive innovation Ability to operate successfully in a global matrix environment with shared accountability and responsibilities. Minimum Qualifications and Experience Degree in relevant technical area ( Analytical, Biochemistry, Biology, Pharmacy) At least 10 years of work experience in relevant area or advanced degree (PhD) in relevant technical area combined with a minimum of 5 yrs work experience Previous experience in Regulatory (Industry or Agency) is preferred In depth Knowledge of China regulatory environment Previous participation and proven effectiveness in international regulatory/industry forums is highly preferred 我们是谁 打造更健康的未来是促使我们创新的动力。全球超过100,000名员工共同致力于推进科学,确保今天和明天的人们,都能获得高质量的医疗资源。我们的努力帮助了2600多万人使用我们的药物进行治疗,我们的诊断产品运行超过300亿次检测。罗氏通过赋能探索新的可能、激发创造力并保持高标准以提供突破传统的医疗解决方案,对全球的医疗环境带去推动和影响。 让我们一起,构建更健康的未来。 罗氏提供平等的职业发展机会。 现在申请 收藏职位 Job Advanced Widget 子类别 综合注册事务 招聘类型 全职 发表日期 04-15-2026 工作类型 未列明 该职位的申请截止时间为上述指定日期的前一天晚上23:59,具体时间以职位所在地的时区为准。 根据您的兴趣定制职位推荐 ​​​​​​​快速注册 profile icon 4 hours. 推荐职位 查看更多 隐藏部分 查看下一页 查看更多

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