法规事务高级专员/经理-医疗器械 Regulatory Affairs招聘_上海药明康德新药开发有限公司最新招聘信息-猎才医药网

职位描述

职位描述： General Summary？Provides technical knowledge and support of clinical trials applications, regulatory requirements for study start up, marketing-authorisation applications, and license maintenance for both internal customers and external clients related to medical devices，drugs and biologicals. Primary job responsibilities include the preparation of regulatory strategy/plan, the preparation and coordination of submissions to support clinical trial application, new drug application, abbreviated new drug application, supplemental applications, etc.？Provide regulatory expertise to the products’ research and development.？Supports business development efforts.？Monitor and assess the regulations and regulatory trends for healthcare and pharmaceutical products.？Participate in project teams and may lead specific regulatory tasks, under the guidance of senior staff.？Response for direct communication of project specifics to external client upon the approval of senior staff.Accountabilities?Develops or reviews regulatory strategy and action plan for internal or external projects.?Provides advises, consults in the area of expertise both internally and to clients.?Prepares or reviews regulatory dossier and ensure timely submission, in compliance with regulations, guidelines and SOPs. Resolve any issue timely to ensure earliest possible registration.?Keeps abreast of current data, trends, regulatory knowledge, developments and advances in the China and global regulatory environment. Ensure any potential impact to projects or company business have been thoroughly well communicated.?Manages and coordinates resources and reviews workload for all direct reports. Guide and support staff to improve knowledge and skill continuously. Reviews performance and provide counseling for direct reports?Provides support to Business Development?Interacts with internal and/or external clients. Identifies and responds appropriately to issues, providing adequate and/or innovative solutions.?Identifies project needs and scope of work, creates project timelines and implements client requests, seeking clarification and senior review, as necessary.?Works with minimal direction, identifies project needs, creates project timelines, and tracks project budgets (where appropriate) for multiple projects and revises and manages scope of work changes, when necessary.?May serve as Project Manager or technical lead on a regulatory project.?Build up and sustain a reliable and professional relationship with regulatory authorities (e.g., CFDA, CDE, NICPBP, Provincial FDAs, Drug Control Institutes).Qualifications?Undergraduate degree or above in medical science or related life sciences area. Over 6 years of regulatory experience in a global leading pharmaceutical company or CRO.?Ability to exercise independent judgment in developing effective resolutions to problems in a regulated environment.?Must demonstrate abilities in scientific knowledge and its appropriate application to regulatory issues.?Extensive knowledge of regulations relevant to the area of expertise.?Ability to work on several projects at once while balancing multiple timelines (i.e., overlapping timelines on one or more projects).?Ability to communicate effectively in both oral and written modes.?Ability to communicate at multiple levels in the organization and in difficult situations.?Must have careful attention to detail and accuracy.?Open attitude and willing to meet challenges.?Must possess strong negotiating skills 职能类别：药品注册政府事务管理

公司信息

药明康德新药开发有限公司于2000年12月成立，是全球领先的制药、生物技术以及医疗器械研发开放式能力和技术平台公司，在中美两国均有运营实体。作为一家以研究为首任，以客户为中心的公司，药明康德向全球制药公司、生物技术公司以及医疗器械公司提供一系列全方位的实验室研发、研究生产服务，服务范围贯穿从药物发现到推向市场的全过程。药明康德的服务旨在通过高性价比、高效率的研发服务帮助全球客户缩短药物及医疗器械研发周期、降低研发成本。十多年来，药明康德成功打造了全方位一体化的研发服务技术平台。创建之初，药明康德凭借其在发现化学合成领域的雄厚实力实现了全面发展。近几年来，我们又新增了一系列一体化服务，包括分析服务、生物分析服务、工艺研究、工艺研发服务、API生产服务、药物代谢及其动力学服务、研发生物学、药理学、制剂、毒理学、基因组服务、生物制剂生产服务、抗体及生物诊断试剂的生产和销售服务以及临床研发和产品注册服务等。从 2000 年 12 月创立至今，药明康德的员工数从4 人增长至 10000 人，实验室由当初仅有的一间增长到近46 万平方米已有及在建研发基地和生产厂房。与此同时，药明康德还在不断增强服务能力，拓宽服务领域，以更好地服务公司持续增长的全球业务需求。作为一家全球领先的医药研发服务公司，药明康德将继续致力于在中美两国为全球客户提供高质量的医药研发服务，帮助研发出更多造福患者的新药及产品。回望昔年，药明康德已经走过了15年的历程。15年走来，我们见证了新药研发的飞速发展，见证了众多科学家在新药研发中实现梦想，见证了全球2000多家企业攻克越来越多的疾病，见证了越来越多患者脸上渐渐浮现的微笑，同时也见证了药明康德人从无到有将药明康德建成一个无论在亚洲还是在全球医药行业里独一无二的研发生产技术能力平台性公司。未来我们的发展方向：一是继续将一体化、开放式的研发生产技术能力平台做大做强，继续延揽建立全球最尖端的医药研发技术，包括基因诊断、细胞基因治疗、基因编辑以及一些高端创新药物的研发、生产等。二是更加致力服务中国的大健康产业，通过我们的平台连接“人与健康”，让国际尖端医药技术能为广大国内患者和老百姓所用。面对2016年，回归成为私营公司的药明康德将更加专注，专注于公司创业之初变革新药研发的梦想。不忘初心，方得始终。药明康德人将继续坚守我们的初心与梦想，在新的征程中，实实在在地推动人类健康。欢迎加入药明康德大家庭，与我们携手一起开启未来，创造未来，享受未来！如需了解更多，欢迎访问公司网站 http://www.wuxiapptec.com.cn

周边城市招聘：上海浙江安徽广东山东河北重庆北京江苏湖南

企业入驻日期： 2017-11-09

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