药品注册专员 上海

月薪： 0.6-1万/月

该公司所有职位
  • 无工作经验
  • 本科
  • 招若干人
  • 11-13 发布
  • 五险一金
  • 通讯补贴
  • 定期体检
  • 年终奖金
  • 交通补贴
  • 员工旅游

职位描述

职位描述： JOB PURPOSE 工 作 目 的  Summarizes the job’s purpose or role and why it exists in the organization  概 述 工 作 的 目 的 或 角 色 及 其 在 机 构 内 的 价 值To implement regulatory strategies to gain rapid and high quality approvals and ensure high standard of regulatory compliance, in order to achieve the company’s business objectives.   NATURE & SCOPE 工 作 性 质 及 范 围     - Internal contacts within Hengrui 内 部 联 系Marketing, Sales, Customer Services, Logistics, Medical, Manufacturing Sites     - External contacts with organizations outside Hengrui 外 界 联 系Local Health Authorities and other Government Agencies, Distributors, Toll Manufacturers, Hospitals and Health Professionals, Key Opinion Leaders (Medical and Regulatory),   (c) Job requirements 工 作 要 求              - Academic / Professional qualification 学 历 / 专 业 资 格?Degree in life science, preferably pharmacy or science with Pharmacology component        - Technical / skills training 技 术 / 技 能 训 练?Possess a high degree of honesty with a track record built on success stories and sound ethics, have a proven track record from a major pharmaceutical company.?Fully understand the current regulatory practices and regulation in China, the authority structure and relationship among different regulatory bodies, knowing and building the relationship with some key customers.-Working experience( no. of years 年 资 job function 工 作 功 能 business types 业 务 种 类 )Essential 必 需?Entry Level: ~1 years regulatory experience in RA function of pharmaceutical company required, typically a scientific degree             Desirable 理 想     - Language ability 语 言 能 力?Excellent verbal and written communication skills and reasonable good enough English, capable in English reading/writing.     - Computer literacy 电 脑 知 识?Good at PC skills     - Others 其 他               DUTIES & RESPONSIBILITES 主 要 职 责   Key Result Areas(in order of importance)% of TimeKey TasksPerformance IndicatorsAdherence to Hengrui and industry code of conduct, ethics and good regulatory practices10%?Align with the values and vision of Hengrui?Ensure regulatory compliance with local legislation, Hengrui code of conduct?Maintain company confidentiality (i.e. intellectual property, product information and strategic information)?Disclose potential breach of codes or conduct?Self display behaviours consistent with the company vision and values?No non-compliance issues raised with the company policies and procedures?No valid complaint, recall, etc. from internal & external customers on “local regulatory approved” components?No breach of confidentialityImplement regulatory strategies to achieve rapid and high quality approval and facilitate rapid launch10%?Coordinate with key stakeholders (local regulatory authority, etc.) to achieve rapid/ high quality submissions and approvals?Prepare and produce high quality regulatory submissions?Monitor registration process and promptly report whenever necessary?Develop artwork required for packaging and coordinate with logistic staff to facilitate rapid launch?New products are registered and launched on or ahead of plan with the best label as agreed in the strategy?Prompt and continual reporting on status to key stakeholdersMaintain product licenses to high standard20%?Monitor and promptly report status of all product licenses?Implement submission plan for products maintenance (license, amendments to update registration files etc.) as approved and deliver plans on time?Maintain complete documentation records.?No unintentional loss of product licenses?Accurate & complete records in placeEffectively manage the regulatory information to ensure good coordination for all stakeholders10%?Maintain and update local regulatory support and information systems, registration templates etc.?Communicate changes to regulatory status to all stakeholders?Provide appropriate support to other functions?Accurate and up-to-date regulatory support system/information?Documented correspondence regarding changes is up-to-date?Relevant stakeholders are well and promptly informed of regulatory changes?Customers feedback on quality of service and information providedUnder supervision: establish relationship with local regulatory authorities20%?Build up good image through high professional standard of application, response to enquiries etc.?Establish good relationships with regulatory authorities through regular contacts?Number of contacts made with regulatory authorities?Regulatory authorities feedbackMonitor local regulatory environments and communicate to key stakeholders10%?Maintain up-to-date knowledge of local regulatory environment?Communicate changes of local regulatory environment?Accuracy of regulatory information provided?Regular report of local regulatory changes?Key stakeholders are well and promptly informed of changes on local regulatory environmentAssist Issue management10%?Provide detailed information on regulatory status of affected products?Undertake assigned follow-up action where necessary?Negative impact on relevant product is minimized?Documentation of fast and effective communication internally and externally so as to achieve objective and resolution at high ethical standards?Positive feedbacks from directorsEffective team work10%?Actively participate in team working?Share best practice examples & learning with the team and regional/global colleagues?Level of contribution as a team member?Feedback from other team members 职能类别： 药品注册 关键字： 药品注册 Regular Affair

联系方式

张江

公司信息

江苏恒瑞医药股份有限公司始建于1970年，2000年在上海证券交易所上市，股票代码600276，是国内最大的抗肿瘤药和手术用药的研究和生产基地，国内最具创新能力的大型制药企业之一。 公司先后被评为“全国医药系统先进集体”、“国家重点高新技术企业”，国家火炬计划新医药研究开发及产业化基地的骨干企业之一，“国家863计划成果产业化基地”，连续多年被国家统计局列为全国化学制药行业十佳效益企业；公司是国家“重大新药创制”专项创新药孵化器基地，是“中国抗肿瘤药物技术创新产学研联盟”的牵头单位；2011年，公司组建的国家靶向药物工程技术研究中心成为江苏省医药企业建立的第一家***工程技术中心；公司位列医药上市企业最具竞争力前三。2013年，公司实现营业收入62.03亿元。 恒瑞医药本着“诚实守信 质量第一”的经营原则，致力于抗肿瘤药、手术用药、造影剂、心血管药及抗感染药等领域的创新发展并逐步形成品牌优势。公司是国内首次通过国家新版GMP认证的制药企业之一，同时也是国内第一家注射剂获准在欧美上市销售的制药企业，在中国制药发展史上具有里程碑的意义。目前公司已有3个注射剂、2个固体制剂、5个原料药通过美国FDA和欧盟认证。 在市场竞争的实践中，恒瑞医药坚持以科技创新为动力，致力于打造企业的核心竞争力。为此，公司在美国、上海、成都和连云港建有四大研究中心和一个临床医学部，拥有各类高层次专业技术人员1200余名，其中有500多名博士、硕士及海归人士，有4人被列入国家“千人计划”，7人被列入“江苏省高层次创新创业人才引进计划”。公司建立了***企业技术中心和博士后科研工作站。2011年9月，公司糖尿病科研团队在江苏省科技创新团队评选中名列第一。 近年来，公司先后承担了4项国家863计划重大科技专项项目、23个项目列入国家“重大新药创制”专项，12项国家火炬计划项目，7项国家星火计划项目，23项***重点新产品项目及数十项省级科技攻关项目。公司共申请了近200项发明专利，其中97项PCT专利，有1个创新药艾瑞昔布已获批上市，2个创新药已申报生产，另有9个创新药处于不同的临床阶段。 恒心致远，瑞颐人生。恒瑞医药一直秉承“科研为本，创造健康生活”的理念，以建设中国人的跨国制药集团为总体目标，拼搏进取、勇于创新，不断实现企业发展的新跨越和新突破。 上海盛迪医药有限公司是江苏恒瑞医药有限公司的全资子公司。公司位于上海浦东张江高科技园区，注册成本2.5亿元，占地面积41000平方米，设有恒瑞新药研发、临床研究、专利注册、医学事务及产品市场管理等核心部门。公司将坚持创新与国际化发展战略，全力打造成为恒瑞医药的创新研发中心。

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