Director, Technical Regulatory

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 Description

Single point of contact for CMC topics and issues related to China submission for assigned products.

Accountable for development, communication and execution of sound regulatory strategies for early stage CTA and life cycle management submissions that meet China regulatory requirements and enable business objectives.

Identification and communication of regulatory risks and development and execution of risk mitigation strategies in concert with local and global teams.

End to end manage early stage CTA and related submissions (CMC amendment, DSUR), including (but not limited to) lead CMC strategy discussion, dossier & documents preparation, submission, QnA, RIM, CTN etc.

Lead response strategy to China Health Authority questions and support tracking of CMC commitments.

Leading and/or coordinating health authority interactions for assigned projects.

Ensuring up-to-date China regulatory requirements are maintained, communicated and integrated into project teams work plan, and proactively prepare for new requirements.

Work together with PDR China Partner to ensure “One Regulatory Voice” in creating strategy and coordinating submission activities.

Partner with China Policy to identify opportunities to shape the regulatory requirements around technical topics interested in Roche.

Accountable for post approval CMC changes, NDA/BLA, CMC process build/improvement as appropriate.

QUALIFICATIONS

Education

Degree in relevant technical areas (Analytical, Biochemistry, Biology, Pharmacy). Master Degree is preferred.

Experience

8 or more years of work experience in the pharmaceutical industry. 5 or more years of CMC RA experience.

Strong proven experience in Regulatory Affairs with focus on early stage CTA submission, and CMC requirements for small molecule/biologic products, development, manufacturing and/or quality experience.

Technical background or experience of diverse modalities is a plus, e.g., ATMP, ADC, oligo, peptide.

Global CTA submission (US, EU, Canada, South Korea, etc) experience is a plus.

Knowledge/Skills/Competencies

Demonstrates effective problem-solving ability, has a strong understanding of regulatory strategies, shows excellent interpersonal skills and has the ability to prioritize multiple tasks.

Has proven ability to influence and work both independently and collaboratively in a team structure.

Strong knowledge of ICH and China regulations and guidelines. Knowledge of EMA, FDA, Canada regulations and guidelines is a plus.

Strong verbal and written communication skills.

Fluent in English and Chinese.

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。