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法规注册专员上海复旦张江生物医药股份有限公司上海0.8-1.5万/月05-11

学历要求:硕士|工作经验:2年|公司性质:合资|公司规模:150-500人

岗位职责:1.项目注册申报: 1)负责申报资料的整理、审核校对等工作; 2)负责公司国内项目申报eCTD文件的整理; 3)负责注册申请递交,协助申报过程中药监的沟通/核查/检验; 2. 其他: 1)中国药品相关法规、政策、技术指导原则更新的及时跟踪、解读,并对公司相关员工的传递、反馈; 2)公司立项调研项目的注册相关支持; 3)协助注册经理完成其他相关工作。任职要求:1. 药学相关专业,研究生或以上学历;2. 具有两年以上药品领域相关工作经验(含QC、制剂研发/生产、QA及临床相关岗位);3. 熟悉国内药品注册相关法规,了解CFDA/ICH等指导原则;4. 具有较好的沟通、协调能力;5. 具有熟练的文献检索、分析及整理能力;6. 具有良好的英语基础,能熟练阅读翻译文献。

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药品注册文员上海欣峰制药有限公司上海-金山区0.5-1万/月05-11

学历要求:本科|工作经验:2年|公司性质:民营公司|公司规模:50-150人

1、药学、药物分析等相关专业,大专以上学历,本科优先;2、一年以上药品注册或药物研究工作经验(优秀应届毕业生亦可);3、专业知识扎实,能独立完成申报资料和审核原始记录;4、熟悉国家相关药品注册法规,熟整体悉药品申报流程及申报表格的填写;5、良好的语言表达能力和沟通能力。6、熟悉使用各种办公软件工作地点:上海市金山区 

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注册专员上海邦耀生物科技有限公司上海-闵行区0.8-1.6万/月05-11

学历要求:本科|工作经验:1年|公司性质:民营公司|公司规模:50-150人

【职位描述】1、监督项目研发、试制和注册申报过程中的合规性,包括但不限于合同审阅、项目申报前自查、研制现场核查、生物安全检查、技术转移等; 2、协助外部供应商及委外研究机构的联络、跟踪和审核沟通;3、跟进与协调公司各部门注册相关工作,及时汇报注册项目进程; 4、配合项目研发、注册申报和后续开发过程中与药品监管审评机构的沟通交流;4、药品申报材料整理协助;5、完成上级安排的其他工作。【任职要求】1、药学、药理学、生物制药、分子生物及细胞生物相关专业,本科及以上学历; 2、有1年以上制药企业或CRO公司相关工作经验,有大分子生物药注册经验优先;3、掌握国内外注册法规及变化内容,有较强的文献检索能力;4、具有丰富的药品注册经验,具有优秀的表达能力,善于培训和主持会议;5、英语水平达到CET4,能熟练操各类办公设备及应用软件; 6、抗压能力强,有良好的职业道德和奉献精神; 7、热爱生活,具有良好的团队合作意识。

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注册专员/经理普霖贝利生物医药研发(上海)有限公司上海-浦东新区1-3万/月05-11

学历要求:硕士|工作经验:2年|公司性质:外资(欧美)|公司规模:50-150人

Role: Regulatory Affairs-China Market具有2-10年法规事务经验,熟悉中国药品注册相关法规Job ResponsibilitiesPreparation, review, submission, query responses and secure approval of different products for the China market.Well-versed with the pre-submission and submission activities of NMPA/CDE for different products.Manage registration document packages. Ensure accurate and timely preparation of regulatory submissions of products, amendments and maintenance of existing registration to obtain timely approval of product registration from NMPA.Manage regulatory and registration activities products in china market.Proactively identify potential regulatory risks and manage impact of regulatory changes within defined scope of responsibility on the business.Support the development and analytical functions in the regulatory issues start from project kick-off to the final submission.Review and analyze R&D, technical, regulatory data, as well as enquiries from marketing, business and trade related to Regulatory.Provide regulatory guidance, consultation, interpretation and advice to relevant departments to ensure compliance with regulatory guidelines/directives/national requirements.Maintain good communication with regulatory agencies/institutes (e.g., CFDA, CDC) on product registration, including but not limited to regulatory inquiries, review committee meetings, sample testing to facilitate and expedite regulatory approvals.Collaborate and communicate effectively with teams internally and external bodies to meet business objectives.Follow NMPA regulations and analysis impacts to business/pipeline or responsible products.Take charge of new products launch in China, including make strategy, control registration timeline,, prepare registration documents, following evaluation and get approvalSkills:Master’s degree or above in  pharmacy/life sciences/bio2-10years in RA experience or in relevant area.Knowledge of registration regulation and procedures in NMPA, NIFDC, CDE, and ICH guidelines.Good communication skillsComplete Product registration for china market        

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Regulatory Affairs Senior Consultant(高级注册顾问)上海彼科意企业管理咨询有限公司上海-闵行区2-2.7万/月05-11

学历要求:本科|工作经验:5-7年|公司性质:外资(欧美)|公司规模:500-1000人

We are looking for a Regulatory Affairs Senior Consultant to support our Regulatory Affairs Department in the registration and maintenance of pharmaceutical products (both finished products and active pharmaceutical ingredients) in China. The resource is expected to provide independent regulatory guidance to product development in strategic planning, pre-marketing, submissions and to support product launches on the Chinese market. The individual leads the submission of licenses and authorizations for the registration and maintenance of pharmaceutical products for the Chinese market. The RA Senior Consultant helps to define data and information needed for regulatory approvals in conjunction with our Regulatory Affairs Department. The role assists in the development of best practices for Regulatory Affairs processes.    Main responsibilities    Ensures compliance with regulatory agency regulations and interpretations.    Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.    Involved with the preparation of necessary outlines, summaries, status reports, project reports, memos and slides.    Provides solutions to a variety of problems of moderate scope and complexity.    Researches, collects data, and responds to requests from regulatory agencies and/or clients to prepare and submit documentation for marketing approvals, as well as to provide routine regulatory information internally and to clients.    Prepares regulatory labeling requirements specifications for new and modified products, and reviews product labeling to ensure compliance with CFDA requirements    Provides regulatory guidance to product development teams and responds to product information requests.    Performs GAP analysis of API and finished product dossier for the Chinese market.    Leverages scientific and technical understanding of regulated products to provide regulatory input to product lifecycle management and evaluate regulatory impact on products. Demonstrates the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with customers’ business objectives.    Engages with local and/or regional regulatory agencies.    Deliver by acting with speed, flexibility, accountability and appropriately managing priorities to deliver results for on-time clearances.        PROFESSIONAL EXPERIENCE REQUIRED     Bachelor degree from accredited college or university in science, chemistry, biology, pharmaceutical biotechnology, pharmacy, medical / scientific writing.    At least 4+ years of regulatory affairs or related/equivalent experience    Experience with domestic regulatory submissions is required.    Experience with or exposure to foreign regulatory submissions.     Experience with Japanese regulatory submissions is a plus.        Languages:    English: Fluent (mandatory) Chinese: mothertongue Japanese : nice to have

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注册主管济川(上海)医学科技有限公司上海-浦东新区20-25万/年05-11

学历要求:本科|工作经验:3-4年|公司性质:民营公司|公司规模:150-500人

岗位职责:1.公司项目注册申报工作,管理项目注册文件;2.为注册项目分析评估及注册策略提供法规方面的专业支持;3.负责制定项目及药品注册服务预算及提案;4.为业务发展部门提供法规及注册支持;5.负责申报资料的审核;6.负责及时收集国内外药品研发趋势和信息,掌握药品注册政策和注册品种的最新动态,并与客户及相关政府部门沟通与协调,确保注册进度;任职资格: 1.本科及以上学历,生物制药、药学、生物工程、制药工程、临床医学等相关专业; 2.3年以上的药品注册与管理经验,有主导完整注册项目的成功案例,有丰富的行业资源; 3.有丰富的专家网络及广泛的信息资源; 4.熟悉SFDA 、FDA相关法规,熟悉国家药审中心的操作流程,对药物开发及申报流程、注册法规有全面的了解,熟悉申报资料的撰写; 5.拥有良好的注册项目管理能力,有效解决问题和组织计划的能力,有较强的领导能力、执行力和抗压能力; 6.具有一定的药化、药理等多个领域的知识储备 7.热爱并看好本行业,有良好的职业道德和奉献精神。

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质量保证部专员上海瑞宙生物科技有限公司上海-浦东新区0.8-1.4万/月05-11

学历要求:本科|工作经验:2年|公司性质:民营公司|公司规模:50-150人

职位要求:1.大专及以上学历,生物或相关领域专业;2. 有制药行业研发或生产工作经验,2年以上质量保证(QA)岗位经验;3. 了解中国GMP等法规、ICH指南中对质量管理的要求,有监管部门审计和检查经验优先;4. 有良好的协调组织能力和沟通能力,有较好的学习能力,细心、可靠、负责;5. 有生物制品产品开发质量管理经验的优先考虑。 岗位职责:协助起草、审核和更新药品研发生产整个生命周期的质量管理规程和文件(研发、临床试验)及公司整体培训计划,督促和维护公司质量体系的实施和持续改进,支持项目从研发、中试到临床试验的合规性执行。位薪资福利:1. 带薪假日:员工可享受员工手册中所规定的重要节假日,期间照常支付薪金;员工转正后可享受婚假、丧假、产假及护理假2. 五险一金:包括养老保险、医疗保险、失业保险、生育保险、工伤保险和公积金。3. 节庆福利:包括婚育礼金、节庆礼包和生日礼包。4. 员工活动:包括部门团队建设、节日主题活动、企业文化活动。 5. 公司提供餐补。

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药品注册专员上海沪源医药有限公司上海-闵行区1-2万/月05-11

学历要求:硕士|工作经验:2年|公司性质:民营公司|公司规模:50-150人

岗位职责1、负责公司进口产品注册工作,包括各国药品在中国境内的首次注册,补充注册,再注册事项;2、负责注册资料整理和编写翻译,协助进行技术及资料分析及立卷审查3、协助组织缺陷答复或发补工作、组织注册核查直至获得上市许可。岗位要求:1、药学、化学及其相关专业硕士以上学历,英语六级以上;2、有药品研发、生产、实验室经验者优先,英语口语流利者优先。

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药品注册经理/药品注册专员奥锐特药业股份有限公司上海-静安区1.2-2.5万/月05-11

学历要求:本科|工作经验:1年|公司性质:民营公司|公司规模:500-1000人

1、本科及以上学历,药学、化学、制药、分析等相关专业;2、制药行业1年以上工作经验优先,国际药品注册1年以上相关工作经验优先;3、英语熟练,书面表达清晰、流畅;4、了解药品生产过程,对药品GMP有一定的了解;5、具有良好的沟通能力,工作细心,诚信可靠,具有良好的职业道德、敬业精神和团队协作精神;6、工作地点在上海市静安区武宁南路488号智慧广场。

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注册专员安源医药科技(上海)有限公司上海-浦东新区0.8-1万/月05-11

学历要求:本科|工作经验:2年|公司性质:合资|公司规模:50-150人

职位描述:1. 负责公司的生物新药产品的境内外注册申报事宜,包括IND,NDA的组织申报资料撰写、递交与受理、审评问题回复、协调现场检查、跟进注册检验、跟踪审评进度及批复事务;2. 负责跟踪、收集国内外药证部门的政策法规,及时汇总、分类、整理、归档监管部门出台的各项药事法规、文件、技术资料,建立国内外注册相关政策信息库,开展公司内部药证法规及指导原则解读和培训工作;3. 参与公司生物新药产品的药学研究,非临床研究和临床研究全过程的实施管理;4. 负责公司新药研发和申报过程中外部沟通和协调,包括NMPA、CDE与FDA等审评专家的沟通,解决药品研发及注册过程中的法规问题;5. 上级安排的其他工作。任职资格:1. 本科及以上学历,生物学、药学、医学等相关专业;2. 具有2年以上生物制品注册申报经验;3. 熟悉药品注册相关的法律法规、申报流程及要求,熟悉药品注册资料和细节条款和各项标准;4.  具有良好的英文读写能力。

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药品注册上海朝瑞化工有限公司上海-徐汇区1-1.5万/月05-11

学历要求:本科|工作经验:2年|公司性质:民营公司|公司规模:50-150人

岗位职责: 按照国家相关法律法规进行药品注册资料的撰写、整理和内部审核; 负责出口药品注册英文资料的独立撰写和整理; 负责注册项目的统筹、协调及项目进度跟踪,及时掌握注册的程序和要求,保证各个环节的顺利进行; 负责与有关部门(药检所,审评中心等)联系,跟踪药品注册进度; 负责关注注册相关的国家政策及法规的更新、搜集、解读与培训,即时汇总、分类、归档药监部门出台的各项药事法规、文件及技术资料等; 及时与研发技术人员沟通,解决药品申报注册中出现的问题; 完成公司临时交办的其它工作。                                        任职要求: 本科及以上学历,药学相关专业,大学英语六级; 2年及以上相关工作经验,熟悉药品申报流程,有药品注册申报成功的经历; 熟悉药品注册相关的法律法规和指南,能独立分析注册过程中出现的问题,有项目管理经验者优先; 具有较强的文献检索能力、沟通及协调能力; 工作认真细致,条理性强,有较强的独立学习与独立工作能力。

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注册专员上海苏豪逸明制药有限公司上海-青浦区0.6-1.2万/月05-11

学历要求:本科|工作经验:无需经验|公司性质:民营公司|公司规模:150-500人

⑴及时查询并熟悉国内、外产品注册的法律法规、药品监管的相关的法规及公告文件;⑵负责制订项目研究计划,负责管理研究项目的进程并收集整理研究数据,并对质量研究结果进行分析和评价;⑶根据相关政策法规的要求整理撰写申报资料,通报各相关部门并进行审核后及时进行申报;⑷跟踪所负责项目的注册进度,及时获取药品注册信息,配合药品监管部门进行申报资料的补充、现场检查及办理相关手续,完成申报流程;⑸根据产品注册状态和企业发展进行相应的补充、变更和再注册工作。⑹根据客户要求,为客户提供所负责项目的相关技术资料。任职资格:1、 药学或相关专业,本科或以上学历;2、 具有良好的中英文文书撰写功底;3、 工作认真严谨,责任心强,解决问题积极主动,具备较强的自我学习能力并可承受一定的工作压力;4、 了解GMP、医药行业注册申报相关法规,熟悉申报流程,有API报批注册文件内容及编制经验者优先;5、有经验者优先。

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药品进口注册专员(北京办公)颐德药业(上海)有限公司异地招聘0.8-1.5万/月05-11

学历要求:本科|工作经验:1年|公司性质:合资|公司规模:少于50人

职责:1. 负责进口原料药/制剂的资料的中英文校对、整理与申报;2. 与药监部门协调沟通,跟踪项目申报进度,解决注册及申报过程中遇到的问题;3. 协助公司其他部门,提供调研及相关支持;4. 负责相关法规的收集,以及注册资料的归档。资格要求:1.熟悉国内药品注册要求,具有1年以上药品进口注册经验者优先;2.有原料药/药品QC分析、制剂研发/药物合成相关经验者优先;3.具有较好的英文阅读能力,能熟练校对中英文药学申报资料;4.具有较好的团队合作以及学习精神。

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注册副总监和铂医药(上海)有限责任公司上海-徐汇区50-60万/年05-11

学历要求:本科|工作经验:8-9年|公司性质:外资(欧美)|公司规模:150-500人

l Provide input to regulatory strategy & timeline and form optimal development and registration strategy for assigned projects under the instruction of RA head, including proactive identification of regulatory opportunities / risks.  l  Lead the preparation of registration dossiers cross functions and be in charge of the timely submission of assigned projects; l  Ensure timely, clear communications on project regulatory status/issues/risks with teams, RA line management, and key stakeholders internally, and with Health Authorities, as appropriate. l  Obtain IND, NDA and other supplement application approval l  Provide regulatory assessment for potential corporate BD projects l  Implement regulatory activities as required by governmental regulations and internal SOPsl  To maintain up-to-date knowledge and expertise of relevant ICH guidelines, NMPA, FDA, and EMA regulations l  Other tasks assigned by leader    职责要求:l  Bachelor or above degree in Life Sciences, Pharmacy or Medicine, or equivalent experience l  At least 8 years in RA and/or drug/biologic development which include at least 6 years of demonstrated accomplishments in RA: l  Management/coaching of junior associates a plus l  Good understanding of pharmaceutical & regulatory environment l  Good relationship with stakeholders related to product registration l  Creative problem solving and strategizing abilities l  Experiences in working with cross-functional teams in a multicultural environment l  Fluency in English and Chinese  (oral and written)

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法规高级专员/副经理联合利华中国有限公司上海分公司上海-长宁区1.5-2万/月05-11

学历要求:本科|工作经验:3-4年|公司性质:外资(欧美)|公司规模:10000人以上

职责描述:? Support innovation for skin cleansing projects (claims, regulatory assessment, etc.), and ensure the OTIF product launch;? Assist in maintaining good connections with various external bodies including regulatory authorities, trade associations and other NGO;? Monitor, evaluate and update product related law and regulation; and advocate the key regulations relevant to skin care products;? Provide regulatory solution to question/problem raised by QA, TPL, Process and other functions;? Work with other functions, e.g. R&D, Legal, QA, PR…to support issue and crisis handling.任职要求:? Bachler’s degree in pharmacy, chemistry, biology, foods or equivalent;? Previous working experience (>3Y) in company of cosmetic/personal care product is strongly desired;? Sound knowledge of law/regulation/standard relevant to PC product, and the procedures of PC product registration/notification;? Good communication & interpersonal skills;? Results-driven; detail-oriented;? Good at written & oral English.

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Associate Scientist/ Scientist, Process R&D和记黄埔医药(上海)有限公司上海-浦东新区0.8-2万/月05-10

学历要求:本科|工作经验:2年|公司性质:外资(非欧美)|公司规模:150-500人

Responsibility:1. Prepare process R&D related documents and reports to support IND and NDA. 2. Update technical documents and effectively communicate with process R&D team.3. Support process R&D team to provide documentation for IND, NDA, IMPD, DSUR, annual report and etc.4.Work effectively with regulatory, analytical R&D, formulation R&D to support all related documents preparation and updates. Qualification:1. Bachelor or Master degree in chemistry or pharmaceutical science.2. Good understanding on process chemistry, pharmaceutical science, drug development. 3. Good English oral and writing skills.4. Familiar with CFDA/FDA/EMA regulations and ICH guidelines, previous experiences with global filings are preferred. 

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Sr. Submission Team Manager(J17705)辉瑞(中国)研究开发有限公司上海-浦东新区3-4万/月05-10

学历要求:本科|工作经验:3-4年|公司性质:外资(欧美)|公司规模:10000人以上

工作职责:To oversee and direct regional/national submission portfolio execution associated with ~40000 submissions worldwide to regulatory health authorities per annum, through leadership and engagement of Hub Submission Managers as part of a global business model.Executes strategic direction, defines and upholds regional submission standards in support of new registrations and full product license lifecycle management to multiple regulatory authorities, maintaining compliance with applicable regulatory obligations while working to tight, business-critical deadlines within a highly regulated environment.Accountable for managing submissions when required to meet business needs and at all times maintain a comprehensive and detailed oversight of process, quality control and regulatory workload within the function.Proactive coordination of load balancing, resources and training in support of cross regional submission activity; assessment and monitoring of trends in portfolio activity that drive changes in operating model.To represent Submissions Management as direct partner for WSR Country Regulatory Heads for designated markets and stakeholder management across partner lines. ManagerPartnership with peers ensuring quality and consistency of processes, directly supervising Hub Submission Managers to ensure Pfizer delivers on key regulatory submission milestones and maintains compliance with applicable regulatory obligations  Responsible for balancing workload within and across regions and resource optimization in support of the global portfolioDrives and executes implementation of global submission policies and strategies to meet evolving business needs, achieving operational excellence through continuous improvementDevelops and executes the optimization and harmonization of hub process to support the flexible resourcing model, ensuring portfolio execution meets time, quality and budgetary requirementsServes as a major source of innovative ideas seeking efficiencies and effectiveness and driving the implementation of technological solutionsUnderstands, interprets and influences technical requirements for electronic Submissions as defined by FDA, EMA, MHLW, ICH and national marketsResponsible for developing partnerships with country/regional leads and key stakeholders to ensure achievement of deliverables and identification of opportunities to gain greater efficienciesResponsible for professional development through mentorship and motivation.Responsible for hub adherence to internal standards and maintains a state of Inspection ReadinessProvides guidance to and leads moderately complex submission and process improvement projects, making decisions independentlyLeads the interpretation of regulatory guidelines to produce business requirements and ensure that those requirements are implemented where appropriate at local level.Manages own time to meet objectives; forecasts and plans resource requirements (people, financial and technology) for projects across DepartmentConsidered a technical resource within the groupMatrix manages global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines. Senior Manager (cumulative from above)Drives communication  and proposes  refinements in the submissions process and related projects through collaboration with stakeholders and regulatory leadersLeads Lessons Learned sessions and implements change in partnership with Dossier Excellence TeamServes as Pfizer SM representative with Health Authority meetings, Industry discussions/ initiativesAccountable for changes in policies and strategies to meet evolving business needsSelf-initiates assignments, developing innovative ideas to resolve complex problems and leading the execution of projectsFunctions as a change agent that can exhibit regulatory knowledge and awareness, technical competence, sound judgment, and a professional demeanorOperates as delegate for SM leadership as required  #LI-PFE任职资格:QualificationsMust-HaveBachelors Degree5+ years of experienceRelevant experience in electronic submissions build within the Pharmaceutical IndustryStrong knowledge of the drug development process, regulatory affairs, and submission managementUnderstanding of systems and electronic technologies used to support submission and planning activitiesAttention to detail and exceptional organizational skillsPresents scientific data effectively, in verbal and written in a logical and persuasive mannerProven experience managing or delivering through others in a team environmentProficient in English, verbal and writtenNice-to-HaveMasters degreeRelevant pharmaceutical experienceFamiliarity with pharmaceutical organizational structures, systems, and cultureExperience in project management

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Regulatory Affairs Manager赢创特种化学(上海)有限公司上海05-10

学历要求:本科|工作经验:10年以上|公司性质:外资(欧美)|公司规模:1000-5000人

RESPONSIBILITIESIn charge of the application and maintenance of drug import licenses for drug substances and their intermediates.Coordination of and guidance to the dossier preparation for China in the international regulatory affairs API-group.Surveillance of new policies for C-DMF to APIs and import licenses in China.Writing and updating of guidance SOPs for registrations of APIs in China. Training of the international regulatory group to registration process in China for existing and new guidelines.Communication with Chinese authorities to follow up on the licenses and C-DMF registration process.Communication with customers in China for business support on regulatory affairs.Communication with associations that may impact Chinese pharmaceutical regulations. REQUIREMENTSBachelor or above with technical, natural science or pharmaceutical backgroundAt least 10 years working on pharmaceutical and API regulatory affairsIndustry group engagementGood knowledge of the quickly adapting Chinese pharmaceutical regulationsSome oversight on pharmaceutical regulations in US, EU, Japan and other Asian countries.Presentation and communication skillsSolution drivenFluency in English and MandarinFluency with MS Office, SAP, and other office applications

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Junior Registration Executive (Contractor)欧莱雅(中国)有限公司上海-浦东新区05-10

学历要求:本科|工作经验:1年|公司性质:外资(欧美)|公司规模:1000-5000人

Junior Registration Executive (Contractor)     Key Job:  Support to product registration to for product launch on time, involving steps belowDossier creation and reviewPackaging verification of AW for products;Sample preparation and detection;Testing preparation;Timely follow-up the product registration process;Communication with internal & external depts.Contribute to regulation compliance projects for the regulation change.                   For Competencies required part, add some more:   Scientific background as Chemical, Biology, and Pharmacy related.Good written and oral communication skillsGood interpersonal skillsProficiency in EnglishGood at Office Software  Working experience in registration and knowledge of regulation and registration matters are a plus.               

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Regulatory Affairs - Associate ManagerAstraZeneca Global Commercial Organization 阿斯利康 GCO中国上海04-27

学历要求:本科|工作经验:3-4年|公司性质:外资(欧美)|公司规模:5000-10000人

职责描述:? Adherence to AZ and industry code of conduct, ethics and good regulatory practices including AZC RA SOPs and other required SOPs.o Align with the values and vision of AZo Maintain regulatory compliance (PI & CMC) with Local legislation, Global regulatory policies, AZ code of conducto Maintain company confidentiality (i.e. intellectual property, product information and strategic information)o Disclose potential breach of codes or conducto Follow SOP requirements especially on documentation? Implement regulatory strategies to achieve rapid and high quality approval and facilitate rapid launch.o Coordinate with key stakeholders (local regulatory authority, local MC and International Regulatory Affairs Group etc.) to achieve rapid/ high quality submissions and approvalso Prepare and produce high quality regulatory submissionso Monitor registration process and promptly report whenever necessaryo Actively communicate with CDE reviewers for technical discussion and Panel Meetingo Develop artwork required for packaging and coordinate with logistic staff to facilitate rapid launch? Maintain product licenses through timely renewal to high standardo Monitor and promptly report status of all product licenseso Implement submission plan for products maintenance (license, amendments to update registration files etc.) as approved and deliver plans on timeo Maintain complete documentation records.? Effectively manage the local and global regulatory support systems/information to ensure good coordination for all stakeholderso Maintain and update local and global regulatory support and information systemso Communicate changes to regulatory status to all stakeholderso Provide appropriate support to other functions? Under supervision: establish relationship with local regulatory authorities.o Build up AZ’s good image through high professional standard of application, response to enquiries etc.o Establish good relationships with regulatory authorities through regular contacts and sponsorship for academic initiatives or trainings? Monitor local regulatory environments and communicate to key stakeholders, support to exert regulatory influence through company initiatives and/or industry association joint forces.o Maintain up-to-date knowledge of local regulatory environmento Communicate changes of local regulatory environment? Assist issue Management.o Provide detailed information on regulatory status of affected productso Undertake assigned follow-up action where necessary? Effective team worko Actively participate in team workingo Share best practice examples & learning with the team and regional/global colleagues任职要求:Education, Qualifications? Bachelor or above in Pharmacy, Medical, Biology or related fieldSkills? 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.? Project management primary lever skill? Chinese and English (proficiency level)? Computer skill: word, excel, power pointExperience? > 2 years experience in below positions.? Experience in drug development, or manufacturing and QA/QC is preferred? China Pharmacist/Physician License is plus.【AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.阿斯利康是一家提供平等机会的企业,我们将考虑所有符合条件的求职者就业。不因残疾、性别或性取向、怀孕或产假状况、种族或民族或族裔出身、年龄、宗教或信仰、性别认同或变更、婚姻或伴侣关系、受保护的退伍军人身份(如果适用)及任何其他受法律保护的特征而产生歧视。】

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