Specialist, 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 – primary duties and responsibilities

Regulatory strategy development and implementation

Responsible for preparation of high quality CMC regulatory documents for the products local/global in accordance with Roche corporate standards and the requirements of applicable health authorities in support of local/global filings, and contribute to the timely regulatory approval for the local manufactured products.

Managing regulatory aspects of change control and ensuring appropriate communication to stakeholders regarding management of technical changes. Provide regulatory support for relevant quality systems such as change control, discrepancy management, as well as Health Authority inspection support as required and/or serving as a liaison with the local health authority on behalf of the site.

Interact with regulatory agencies on defined matter.

Keeping TRL (CTP, relevant stakeholders) fully apprised of project status and potential submission risks and impact to defined regulatory strategies and timelines.

Help ensure cross-functional coordination and escalation, as needed.

Contributing to regulatory excellence by identifying opportunities, mitigating risks and supporting continuous improvement.

Supporting departmental business processes to document and improve best practices and work efficiencies.

Supporting CMC SME team leader, collaborate with the China technical partners and China Partners in PDR China to facilitate "One Regulatory Voice" supporting assigned regulatory submissions for IND, NDA/BLA, major and/or complex variations activities across the product lifecycle portfolio.

Supporting CMC SME team leader, collaborate with the Regulatory Policy group, effective and timely monitoring of NMPA guidelines and trends, translating China CMC requirements into practice for global project teams, including up to date maintenance of PTR filing standards for China (Model Documents).

Supporting product related maintenance and Quality System activities as assigned (e.g., health authority commitments, health authority inspections, discrepancy assessments)

QUALIFICATIONS

Education

Master’s Degree in life science disciplines is preferred;

Experience

3 or more years’ work experience in the pharmaceutical, biotechnology or related industry in CMC, Regulatory, Quality, R&D, and Manufacturing or related.

Experience on generating technical registration dossier for China/EU/USA is preferred.

Analytical development, or MSAT, or manufacture process development, supply chain experience would be a plus.

Filing experience in Regulatory Affairs is a plus

Knowledge/Skills/Competencies
Technical Knowledge

Knowledge of regulations and guidelines in China and other major markets (e.g. ICH, Pharmacopoeias, NMPA, FDA, EMA, WHO).

Proficiency with a wide range of data/information (CMC, clinical, non-clinical).

Business Acumen

Knowledge of drug development, commercialization process and Pharmaceutical Quality Systems.

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。