北京招聘

PURPOSE
1.    In accordance with the company’s product launch strategy, lead and coordinate the process of drug registration and ensure the
        compliance of technical documentation and process to guarantee the success of drug registration.
2.    Complete related registration work of established product during the registration cycle to ensure the continuous effectiveness of
        Import Drug License.

RESPONSIBILITIES
1.    In accordance with the company’s product launch strategy and department’s work plan, take full responsibility of the product
        registration and application for approval and develop the plan by stage. Contribute to decision making on drug registration
        leading to minimal registration timeline.
2.    Guide subordinates to solve the problems occurred during drug registration in uncertainty Chinese pharmaceutical environment
        to achieve drug registration approvals in timely and cost effective way.
3.    Summarize product registration related materials with coordination among head office, factory, Sales & Marketing. Provide
        corresponding support for the sales in China market.
4.    In accordance with the plan of product registration and application for approval, manage the necessary materials and
        information during the process and track and summarize the progress.
5.    Be responsible for submission of complete and qualified product application data to drug regulatory authorities, coordination of
        raw data review and on-site assessment.
6.    Manage and archive examination and registration materials and other relevant documents.
7.    Provide necessary support to the preparation and implementation of clinical trial.
8.    Establish influential relationships with key regulatory authority individuals and KOLs in relevant fields, such as SFDA, CDE,
        NIFDC, PIDC and etc. Monitor regulatory environment and collect important information such as regulations, guidelines,
        competitive products and etc.
9.    Establish and maintain internal/external channels of communication.
10.    Ensure regulatory activity is in compliance with authority and Takeda policy.
11.    Coordinate with the establishment of internal SOP and system.

职位要求：
Level of Education: Bachelor Degree or above majored in medicine or pharmacy.
Working Experience in Relevant Field: >5 year related work experience
Professional Knowledge and Skills: Skilled in using computer office software.
Good English in listening, speaking, reading and writing.
Be familiar with the laws and regulations of drug administration and registration management, stronger professional competency, excellent communication skill and leadership.

武田成立于1781年，最初是由武田长兵卫（Chobei Takeda）开创的一家在大阪经营日本和中国传统草药的店铺。1871年，武田长兵卫四世开始进口“西药”。从那时起，武田逐渐成长为一家集研发、制造和营销为一体的现代化企业。2009年，武田药品工业株式会社进行重组，从一家具有全球业务的日本制药公司转变为一家将总部设在日本的全球化制药企业。2011年，武田收购了奈科明公司及奈科明与上海医药合资的天普药业，进一步拓宽了武田在全球，尤其是中国市场的进口、分销和客户服务网络。
在创立230多年后的今天，武田在全球拥有约30,000名员工，业务和运营覆盖超过70个国家和地区。每年，武田将全球总营业额的大约20%投入研发。超过700个产品覆盖六大关键治疗领域：心血管与代谢、肿瘤、呼吸与免疫、中枢神经系统、普药、疫苗，销往全球90多个国家和地区。
武田的国际品牌标志代表一座桥梁，象征着武田连接起***突破和满足病患需求的诊疗方案，也象征着武田和医疗保健服务密切相关的病患、医生等社会成员紧密联系。“武田主义”是武田的企业理念之本，是在其所有运营活动中坚守的核心价值。武田承诺，在任何时候，尤其是面对困难与挑战时，公司都奉行以公平、正直和坚毅为基础的“诚信”准则。
武田为成为一家真正的全球化制药企业而不断努力，希望能提供满足各种各样医疗需求的解决方案，为全世界人们的生命健康和美好未来做贡献。