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Talent Acquisition Partner · 罗氏中国

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职位介绍: 罗氏促进多元化、公平性和包容性，代表我们所服务的社区。在全球范围内处理医疗保健问题时，多元化是成功的关键因素。我们认为，包容性是理解人们不同医疗保健需求的关键。我们共同拥抱个性，共同抱持对卓越护理的热情。加入罗氏，每个声音都会得到重视。职位 GENERAL POSITION SUMMARY Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves tracking/control systems. Keeps abreast of regulatory procedures and changes. May direct interaction with regulatory agencies on defined matters. Recommends strategies for earliest possible approvals of clinical trials applications. Works independently within guidelines and policies, receives minimal guidance. Acts as a resource for colleagues with less experience and provides functional guidance. JOB DESCRIPTION – primary duties and responsibilities * 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. * Contributing to regulatory excellence by identifying opportunities, mitigating risks and supporting continuous improvement. * Supporting 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. 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 ICH, WHO, China regulations and guidance. Knowledge of regulations and guidelines of other major markets (e.g. FDA, EMA) is a plus * Proficiency with a wide range of data/information (CMC, clinical, non-clinical) 我们是谁在罗氏，来自100个国家的100，000名员工不断推动着健康医疗行业的进步。我们一同工作，使罗氏成为了世界领先的以研发为基础的健康医疗集团。我们的成功源于创新、求知和多元化，也源于我们把相互间的差异作为一种优势。为了革新医疗健康领域，罗氏设定了远大的计划，坚持学习和发展，并不断寻找与之志同道合的伙伴。罗氏提供平等的职业发展机会。

其他信息: 行业要求：全部行业; 所属部门：全球药品开发中国中心

公司简介

罗氏成立于1896年，总部位于瑞士巴塞尔，拥有125余年悠久历史。罗氏致力于不断探索从前沿科学到疾病诊断和治疗药物的成果转化，挽救生命、改善人类生活质量，在抗肿瘤、免疫、抗感染、眼科和神经科学领域拥有差异化药物。作为个体化医疗的倡导者，罗氏不遗余力地推进医疗健康发展，以期创造更大价值。凭借制药和诊断两大领域的独特优势，结合临床实践中的数据洞察，罗氏积极携手合作伙伴，致力于为每位患者提供合适的治疗方案。罗氏总部位于瑞士巴塞尔，业务遍及全球150多个国家。罗氏连续15年位列道琼斯指数（DJSI）制药、生物技术和生命科学领域可持续发展的全球先行者之一。这是对罗氏携手全球合作伙伴，为提升医疗健康可及性长期贡献的高度认可。美国基因泰克公司（Genentech）是罗氏集团的全资子公司。此外，罗氏也是日本中外制药株式会社（Chugai）的控股方。更多关于罗氏集团的信息，请登陆罗氏全球网站 www.roche.com。

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