RA-主管

20-30万元/年

苏州市本科及以上

刷新时间：2023-06-21

职位描述

    岗位要求：
   • M.Sc. Pharm degree or equivalent, fulfill the legal requirements for a Qualified Person.
   • Have previous experience (5 Years) as Responsible (Qualified) Person or a management role in Regulatory Affairs supporting clinical/commercial biologic manufacturing for a contract or development/MAA corporation.
   • Have excellent organizational skills and the ability to work on a number of projects simultaneously
   • Flexible and enjoy working both independently and in groups
   • Self-motivated, driven and have excellent ability to cooperate with internal as well as external stakeholders
   • Expert knowledge of Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP) encompassing documentation and operation of pharmaceutical facilities including C-FDA, Eudralex, PIC/S and US-FDA with focus on biological API and sterile product manufacture.
   • Detailed knowledge in the design, implementation and maintenance of Regulatory Operations and Systems for global compliance.
   • Thorough understanding of mAb development, manufacturing, and analytical process.
   • Demonstrated capability and enthusiasm to establish high-performance teams.
   • Advanced computer system and database skills.
   • Excellent communication skills in Chinese and English to engage with personnel from multiple disciplines and experience bases across the operations organization to facilitate cross functional communication and planning for the coordination of RA requirements and solutions across locations and countries (China, USA, etc.).
   • Exposure to company and facility start-up.
   • Strong prioritization and organization skills.
   • Detail oriented, flexible, self-initiative.
  
   The preceding statements are intended to describe the general nature and level of work being performed by people assigned to this role. They are not intended to be an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.
  
  
   岗位职责：
   − Responsible for oversight and direction Regulatory operations at AA’s Suzhou manufacturing facility.
   − Support Head of QA acting as interface representing Regulatory Affairs (RA) in intra company and client/customer interactions.
   − Advise quality operations for corporate facilities and operations to ensure compliance.
   − Responsible for the establishment of the functional Regulatory Affairs (RA) organization.
   − Implementation of corporate RA Management Systems aligned with AA strategic and corporate objectives spanning the following areas:
   − For assigned client products/projects, responsible for the independent and timely procurement and examination of the documents required for the registration, declaration of conformity and approval form the specialist departments.
   − The timely and independent creation of dossiers or their precursors according to the statutory and official requirements of the target countries.
   − Accountable for assessment of product changes within the scope of the change control process to determine the permissibility for authorization and responsible for the implementation and tracking of the approved changes, including proactive coordination.
   − Provide cross functional support to internal AA departments to ensure sustainability and continuous improvement in all compliance and quality functions.
   − Participate as a standing member of the Quality Management Review committee.  

其他要求

招聘人数：4人
职能类别：注册部经理/主管

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。