【Sr. Regulatory Affairs Manager招聘】_默克投资(中国)有限公司招聘信息-猎聘

王女士一周前在线已认证

默克投资（中国）有限公司

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职位介绍: 职责描述： Global Responsibilities  Update Allergopharma RA on significant changes of regulations or new regulations issued by the regulatory authorities,  Analyze impact of regulatory environment change on BU business and propose actions which Allergopharma RA needs to take Local Responsibilities  Fulfill RA responsibility for BU business  Develop and implement registration strategy and plan for new products in align with BU growth strategy  Ensure validation of existing products in terms of license, variation, labeling and packaging without impact on BU business in a timely manner  Keep a good communication with the regulatory authorities to ensure any regulatory application of BU to obtain an optimal results and timely feedback on the request from regulatory authorities  Set up process & infrastructure for documentation, dossier preparation and information provided to regulatory authorities as request  As RA role, contribute to the company systems development such as SOPs, working procedures etc. to ensure operational efficiency. 任职要求： • Minimum of 7 years regulatory experience in the pharmaceutical or biotech industry • Excellent understanding of local regulations, guidelines and requirements • Proven expertise in preparing or managing regulatory submissions and achieving approvals • Demonstrated experience in interaction with regulatory authorities

其他信息: 所属部门：Allergy Business Unit

公司简介

我们公司是一家全球**的医药健康、生命科学及高性能材料公司，以创新和高科技优质产品闻名世界。我们公司在全球拥有5万名员工，致力于不断发展改善并加强生活质量的技术——从治疗癌症或多发性硬化症的生物制药疗法，服务于科研和生产的**系统，到运用于智能手机和液晶显示屏电视的液晶。我们公司成立于1668年，是全球历史最悠久的制药与化工公司。家族作为公司的创始人至今仍持有我们大部分的股份。

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