Regulatory Affairs Officer – PD China

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

Job Summary:

We are seeking a proactive Regulatory Affairs Officer to support China regulatory strategy and end-to-end execution for clinical development, product registration and lifecycle-management activities. You will work closely with global and China regulatory colleagues, cross-functional colleagues and China health authorities to help bring tmedicines to patients.

The Opportunity:

Support the development and execution of China regulatory strategies, assessments and submission plans for clinical trials, new product registrations, line extensions and post-approval changes.

Prepare, review and coordinate high-quality regulatory documentation and submission packages; track milestones and support timely responses to authority questions.

Support communications, meetings and procedures with China health authorities, under appropriate guidance.

Contribute to regulatory intelligence by monitoring evolving China and global regulatory requirements and sharing relevant insights with project teams.

Maintain complete, accurate and inspection-ready regulatory records in line with applicable requirements, company policies and data-integrity standards.

Who you are:

Bachelor’s degree or above in pharmacy, life sciences, medicine, chemistry or a related discipline.

Background in pharmaceutical Regulatory Affairs (RA) or R&D; prior experience in regulatory affairs is strongly preferred.

Working knowledge of China drug-registration requirements and an interest in keeping current with the evolving regulatory environment.

Strong written and verbal communication skills in Chinese and English; able to prepare clear, accurate technical and regulatory documents.

Strong sense of responsibility and ownership, effective project coordination skills, attention to detail and the ability to manage multiple priorities and timelines.

Possess strong cross-functional collaboration skills, with a proven ability to effectively coordinate cross-departmental efforts and support team operations during project execution.

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。