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VP / Director, Regulatory Affairs

面议

上海市

刷新时间:2天前

职位描述

Responsibilities:

•Fully responsible for the registration and reporting of the company’s products, including registration strategy formulation, document writing and submission, obtaining approval timely. Regularly monitor registration regulations and competitive product information to provide regulatory support for the company's innovative drug registration;

•Analyze, evaluate and set up the registration strategy;

•Keep contact with R&D department from research and development to project registration, follow up and supervise project progress;

•Master the FDA's requirements for registration information, and understand the relevant ICH, FDA, WHO guidelines for drug registration;

•According to FDA, responsible for writing, reviewing, editing of international drug registration documents, tracking and controlling the progress and quality of data writing of relevant departments within the company;

•Tracking the progress of the drug registration, timely obtaining and updating drug registration information, effective communication with the official, grasp the registration dynamic information, and obtain the registration certificate as planned;

•Establish and maintain good working relationships with customers and drug regulatory agencies.

Qualifications Requirements:

•Fluent in English listening, speaking, reading and writing, able to independently write (review) English application materials and conduct academic exchanges with foreign experts;

•Familiar with the CFDA drug registration process, have a comprehensive understanding of the drug development and declaration process, and registration regulations; prior experience with US FDA drug registration is preferred;

•skills (verbal and written) and negotiation skills;

•Agile thinking, good ability to find problems and solve problems independently, have strong flexibility;

•More than 10 years of experience in drug registration and registration, and successful registration of new drugs;

•35-55 years old;

•Requirement to go through the entire process of registration and marketing of original research tumor drugs in China and achieve successful marketing.

其他要求

  • 1人
  • 生产/质量

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业,总部位于杭州,下属有上海、南京、广州、武汉等多家分公司,同时自主开发国内领先的猎头办公系统及医药人才网站,全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台,在欧、美、日等国家建立了海归引进平台,同时积极开展医药高等院校公益系列讲座,搭建了以人力、企业为主体的立体化咨询服务网,为医药企业人才队伍建设发挥了积极重要作用,为很多医药企业解决了高端人力之困。

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