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Sr. RA Officer梯瓦医药信息咨询(上海)有限公司北京-朝阳区15-20万/年01-16

学历要求:本科|工作经验:1年|公司性质:民营公司|公司规模:5000-10000人

Job Summary: Responsible for the operation of Regulatory Affairs Activities of Teva Generic / new product portfolio of Respiratory and Regulatory system operation, including GI system coordinating and training, regulatory submission and maintenance activities, to ensure timely submissions / approval of responsible products and delivery of regulatory intelligence. Major Accountabilities: Assistant on all regulatory activities of development compounds (registration) and marketed products (life cycle management) in Respiratory TA. Responsible for new product and Gx registration, product license renewal, variation and clinical trial application, including prepares registration dossiers correctly and timely. Prepare product labeling correctly and timely Prepare and compile regulatory dossiers for submission and ensure submission projects are on track and filed in a timely manner. Support China operations on relevant legislation, directives and regulations within China including Gx and Specialty business in responsible TAs Work closely with internal partners to ensure compliance with internal process and external regulatory requirements Responsible for the related Regulatory system and database coordination and training e.g. GI. Qualifications & Requirements: At least University Degree in life science, medicine, pharmacy or material science. At least 1 years’ experience of regulatory affairs in the pharmaceutical industry Basic knowledge of regulatory and healthcare system in China. Strong English communication skills both written and oral in view of building effective stakeholder relationship Excellent interpersonal skills , teamwork and collaboration Innovative and creative, openness to change and ability to think out of box. Results oriented, entrepreneurial and self-motivating.

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项目专员(注册)北京杭州泰格医药科技股份有限公司北京-朝阳区1-1.5万/月01-16

学历要求:硕士|工作经验:1年|公司性质:合资|公司规模:5000-10000人

工作职责:1、参与注册项目的计划、准备及执行,确保项目成功注册; 2、编制注册申请资料并准备其他法规文件,确保经内部审阅和批准之后的资料及时递交; 3、维护注册文件的存档; 4、关注法规的变化,确保所提交的资料是符合法规要求的并且适用于不断变化的法规;任职资格:1、药学或医学相关专业硕士及以上学历; 2、1-2年CRO或制药公司工作经验,第三方实验机构或注册工作经验优先; 3、擅长文案工作,对相关注册法规有一定的了解; 4、具有较好的中英文口语/书面沟通能力,CET6; 5、熟练掌握计算机操作,熟练掌握office办公软件如Excel, Word, PowerPoint; 6、认可公司敬业合作、正直诚信、实事求是、开放包容的价值观。

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进口药品注册专员北京远方通达医药技术有限公司北京-丰台区0.8-1.5万/月01-16

学历要求:本科|工作经验:1年|公司性质:民营公司|公司规模:150-500人

负责公司各项目的注册申报,指导研发人员按法规要求规范研发;跟踪国内外药政法规动态,及时对研发人员进行培训;负责政府部门项目申报工作;协助其他部门处理国家、省市药监局、质监局、药检所等上级部门相关事务;为公司研发项目立项提供参考意见,参与公司研发项目管理;完成领导交办的其他事务。任职要求:具有药学及相关专业硕士研究生以上学历,从事药品注册或研发两年以上;精通药品注册法规,熟悉药物研发全过程,熟悉药品注册要求与流程;有良好的沟通协调能力,有良好的文字整理能力,在医药界有较好的人脉福利待遇:入职即上社保;每天的零食,下午茶,定期的公司团建;员工生日、员工父母生日补贴;各种节假日、假日礼品、过年额外5天带薪假期;温馨的员工宿舍,为员工解决租房烦恼。对于优秀员工的出国游、奖金、补贴

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注册主管费森尤斯卡比(中国)投资有限公司北京1.5-2万/月01-16

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:1000-5000人

岗位职责:对所负责的产品,实施相关注册工作,包括注册资料准备、资料递交、现场核查、质量复核等相关工作,追踪并推动所负责产品的注册进程。负责组织并跟踪药品注册进度,及时获取药品注册信息。参与注册策略的讨论与注册相关机构及公司各部门进行有效沟通,保证注册的顺利进行。负责公司产品各类包装及说明书内容的审核。根据部门需求,提供相关operation和compliance的支持,如SOP更新,存档compliance的管理等。任职资格:工作经验:3年及以上药品注册相关经验。有进口药品注册经验的优先。学历: 学士及以上专业:药学或相关专业。专业知识:熟悉其它知识和技能:良好的沟通能力,英语熟练,包括口语和书面语言,计算机操作技能熟练。

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药事注册 高级主管协和麒麟(中国)制药有限公司北京20-30万/年01-16

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

岗位职责: 招聘岗位:药事主管主要工作职责: 1.参与公司项目立项的前期调研,收集相关药品信息和药政法规要求及文献,了解项目注册计划;2. 负责药品注册申报资料的翻译、整理、制作并及时提交申请;3. 协助经理完成药监部门的各种审查,积极与受理部门、药检机构和审评中心等药监当局联系,跟踪注册进度,及时掌握注册信息;4. 根据生产实际需要计划,按时获得一次性进口、特殊药品进口等进口批件;5. 负责药品注册相关文献资料、竞争产品信息的检索及翻译;6. 协助药事经理召开各类项目会议,并撰写会议记录;7. 协助药事经理识别并解决注册中遇到的各类风险与问题;8. 及时跟进法规变化以及相关的技术要求;9. 承担药品监管政府法规宣传任务,向各部门提供药品监管的政策法规信息;10. 完成上级领导或项目经理分配和其他工作。 招聘人数:1名 工作地点:北京任职要求: 1. 性别:男女不限; 2. 学历:本科及以上; 3. 专业:医药等相关专业,熟悉药品注册流程及相关法规; 4. 工作经验:1年及以上; 5. 语言要求:英语或日语熟练; 6. IT要求:能够熟练操作Microsoft Office; 7. 其他要求:良好的沟通能力,具有团队合作精神。 期望到岗时间: 尽快 待遇: 面议

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FESCO代500强药企招聘RA北京外企人力资源服务有限公司北京-朝阳区0.9-1.1万/月01-16

学历要求:本科|工作经验:1年|公司性质:国企|公司规模:10000人以上

o 根据注册(以及延续注册)策略和注册项目计划,计划并执行项目注册工作。o Plan and execute project registration activities according to the registration (and renewal) strategy, registration project plan.o 准备注册资料和产品技术要求。o Prepare the registration dossier and product technical requirement.o 与项目团队密切合作,以确保注册工作按照项目时间表进行。o Work closely with project team to ensure registration activities meeting project timeline.o 与直线经理共同为法规事务部和跨职能项目团队成员确定项目或项目的优先级。o Define priorities together with line manager on assigned projects or across multiple projects, for RA and cross functional project team members.o 及时提供高质量的苏州工厂文件,以支持国际注册工作。o Support the international registration by providing outstanding Suzhou documents on time.o 支持生产和研发部门的工作,及时审阅相关变更。o Support the manufacturing and R&D activities and review related changes on time.o 支持产品转移完成法规相关工作,包括在全球法规事务部的协助下进行产品分类、产地确定和时间表制定。o Support the product transfer and complete the regulatory action including the classification, made in and timeline with the support from global RA.o 协助原材料和包装材料本地化项目和其他全球项目,在全球法规事务部的协助下进行法规影响评估。o Support the raw material and packaging material localization projects and other global projects to provide the regulatory impact assessment with the support from global RA.o 支持内部/外部审计。为团队提供法规指导。o Support the internal/external audit. Provide regulatory guidance to team.o 维护与内部合作伙伴,包括全球法规事务部,本地质量、研发和生产部门的合作关系。与这些职能部门的合作伙伴有效地沟通。o Maintain the relationships with internal partners, including global RA, local quality, R&D and Manufacture. Effectively communicate with these functional partners.o 鉴别、评估并解读新政策与法规,以支持产品开发和注册。 o Identify, evaluate and interpret new policies and regulations for product development and registration.任职要求:拥有医学、材料学、机械/生物机械工程或制药专业学士或以上学位。B.S. or above in medical, material, mechanical/biomechanical engineering or pharma.span>熟悉中国和其他国家(如适用)的医疗器械法规和注册流程;具备产品设计流程、产品特点、产品检测和生产流程相关知识。Familiar with China and oversea regulations (if applicable) of medical device and registration process, having knowledge of product design process, product feature, product test and manufacture process.span>拥有良好的沟通技巧,可通过有效使用书面和口头沟通或演示对外部及内部决策产生影响。Good communication skills to influence internal and external decisions, by effectively utilize both written and oral communications or through presentations.中英文流利。Fluent in both Mandarin and English.

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注册专员北京欧博方医药科技有限公司北京-海淀区0.8-1.2万/月01-16

学历要求:本科|工作经验:2年|公司性质:合资|公司规模:150-500人

1、负责国内药品注册申报工作,包括临床批件备案、提交注册资料、整理提交注册资料、整理提交补充研究资料、确定药品质量标准说明书等资料、送检药品质量复核、协助批准文号申报工作等;2、负责研发中心相关基金、项目、专利的申报和维护工作;3、负责公司创新药的文献检索、翻译和整理工作;4、协助研发中心项目部进行新项目立项和管理工作;5、上级领导交代的其他任务。职位要求:1、药学相关专业、小动物医学专业本科及硕士以上学历;2、具备较强的文字组织能力、沟通协调能力和团队合作精神;3、英语良好,可独立检索、翻译和整理国外文献资料;4、有一定的化学药品注册申报经验者优先;

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Regulator Affairs Manager赛诺菲(中国)投资有限公司北京-朝阳区3-4万/月01-15

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:5000-10000人

Who we are? As a global healthcare leader and a Global Top Employer, we are as much a partner to patients facing health challenges as we are a partner to you on your career journey. We are focused on empowering our people to be agents of change, because the work we do will change health outcomes and empower patients’ lives. This is where you will have access to a broad track for all-round development as well as the platform to work as one team across one of the broadest healthcare and well-being portfolios globally. Why start your career path in Sanofi? Here, you can: - Have broad presence and resources within large scale international trials and strong new product pipeline - Copperate with strong, independent technology group and experience digital & innovative ways of working - Be viewed as a trusted partner, shared goals and quality work What you can contribute? ? Contributing and facilitating regulatory strategy for the responsible projects with the guidance of senior regulatory manager,and being accountable for HA interaction for regulatory strategy assessment ? Being accountable for the regulatory strategy implementation by CTA / NDA submission / approval ? Being accountable for the LCM mantainance of marketed in China and provide regulatory support for QC testing to secure commercial supply ? Leading regulatory operations for the assigned products in China ? Working with related functions to support business timely What you should have? ? Bachelor’s degree or above in clinical medicine or pharmacy ? >=5 years in RA experience and industry experience ? Knowledge of registration regulation and procedures in NMPA, NIFDC, CDE, and ICH guidelines ? Good command of English (written and spoken) If you want to be part of a team that puts patients first, plays to win in digital era with courage, integrity, respect and trust, to inspire your own career journey through a care & collaborate platform, and with special focus on below competency: ? Team player with good communication, negotiation and influencial skills ? Good planning, organization, strategic thinking and leadship skill

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Regulator Affairs Manager赛诺菲(北京)制药有限公司北京-朝阳区3-4万/月01-15

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

Who we are? As a global healthcare leader and a Global Top Employer, we are as much a partner to patients facing health challenges as we are a partner to you on your career journey. We are focused on empowering our people to be agents of change, because the work we do will change health outcomes and empower patients’ lives. This is where you will have access to a broad track for all-round development as well as the platform to work as one team across one of the broadest healthcare and well-being portfolios globally. Why start your career path in Sanofi? Here, you can: - Have broad presence and resources within large scale international trials and strong new product pipeline - Copperate with strong, independent technology group and experience digital & innovative ways of working - Be viewed as a trusted partner, shared goals and quality work What you can contribute? ? Contributing and facilitating regulatory strategy for the responsible projects with the guidance of senior regulatory manager,and being accountable for HA interaction for regulatory strategy assessment ? Being accountable for the regulatory strategy implementation by CTA / NDA submission / approval ? Being accountable for the LCM mantainance of marketed in China and provide regulatory support for QC testing to secure commercial supply ? Leading regulatory operations for the assigned products in China ? Working with related functions to support business timely What you should have? ? Bachelor’s degree or above in clinical medicine or pharmacy ? >=5 years in RA experience and industry experience ? Knowledge of registration regulation and procedures in NMPA, NIFDC, CDE, and ICH guidelines ? Good command of English (written and spoken) If you want to be part of a team that puts patients first, plays to win in digital era with courage, integrity, respect and trust, to inspire your own career journey through a care & collaborate platform, and with special focus on below competency: ? Team player with good communication, negotiation and influencial skills ? Good planning, organization, strategic thinking and leadship skill

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药品注册专员北京华润北贸医药经营有限公司北京0.8-1万/月01-14

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

岗位职责:1. 按照公司目标,制定申报计划,完成所负责新药的国内或国际注册工作,包括IND/CTA,NDA/BLA等,并负责跟进后续的维护更新工作;2. 负责规划产品注册申请的时间与计划,负责注册申请文件资料的检索、翻译、撰写、编辑、审核和递交;3. 负责与CDE等部门联系沟通,确保各个注册申请的报送、审评和审批的顺利进行,实时跟踪产品注册进程,协助解决注册过程中出现的各种问题;4. 掌握NMPA/FDA对申报资料的要求,提供法规支持,协助解决研究过程中遇到的问题;5. 及时汇总、分类、整理、归档NMPA/FDA等药监部门出台的各项药事法规、文件、技术指导原则,为公司决策提供建议;6. 负责对现有项目的日常维护、资料更新、文献检索翻译等工作,妥善保管药品注册文件;7. 建立并保持政府部门之间良好的关系;8. 完成上级交办的其他工作。任职资格:1. 生物学、药理学、药学或者临床医学专业本科或以上学历;2. 具有3年以上注册工作经验,能独立开展相关工作,具有成功申报经验者优先;3. 熟悉CFDA、FDA和EMA等国家或地区的注册法规指南及药品注册流程;4. 熟悉CTD、eCTD格式申报资料的撰写要求;5. 具有良好的中文文字表达能力及扎实的文字撰写功底;6. 具备优秀的沟通表达能力、团队协作,工作责任心强,细致严谨。所属业务单元:华润三九处方药事业部 – 北京华润北贸医药经营有限公司华润三九处方药事业部,以“解决治疗需求”为使命,对内以“专业,专注,进取”为核心价值观持续转型升级,对外开展多元化合作不断夯实管线布局,致力成为国内处方药细分领域(消化、骨科、心脑重症、肿瘤等)强有力的竞争者。

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DRA Manager, Operation勃林格殷格翰(中国)投资有限公司北京分公司北京-朝阳区01-12

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:10000人以上

Talent@Boehringer IngelheimAbout Human Pharmaceutical Business With global presence, Boehringer Ingelheim has industry-leading expertise in medicine research and development. We are constantly developing the next generation of medical breakthroughs and successfully delivering innovations to meet the medical needs of the patients we serve in the following key areas of interest: cardiovascular, respiratory, metabolic diseases, immunology, oncology and central nervous system. In the future, we will accelerate the launch of more than 10 innovative medicines to meet the demand of Chinese patients. Job Responsibilities Lead the launch of China e-CTD submission project, including but not limited to delivery China eCTD related regulations to global and local stakeholders, validate systems, establish processes etc. As a subject matter expert in eCTD, gives training and provides guidance to project teams on eCTD related processes and local regulatory requirements etc. Centrally coordinate RA regulatory submissions and publishing, including technical support to eCTD submissions Other harmonization work in LRA (Local RA) Qualifications -Education/Degree Requirements: Bachelors degree or above (e.g. MBA, MSc) -Major: Pharmaceutics, Chemistry, Biology or similar preferred -Language skills & proficiency: Good written and oral communication skills in the English language -Required capabilities (skills, experience, competencies): Good project management skill and experience. Be able to work with a keen sense of urgency and priority. Strong learning ability; Good relationship & experience with relevant authorities is preferable; Good personalities with team spirit; Good interpersonal and communication skills -Required working experience: More than 5 years working experience in pharmaceutical company and at least 2 years working experience in eCTD

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EG-Manager, GCMC China-Beijing(J16293)辉瑞制药有限公司北京-东城区3-3.5万/月01-09

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:5000-10000人

工作职责:Job SummaryCollaborate with departmental and cross-functional colleagues (eg. G-CMC, WSR, WRO, and PGS) to leverage and share both technical & regulatory knowledge, align expectations and manage planning and monitoring activities to mitigate risks, contribute to global regulatory strategies, deliver expeditious and efficient regulatory submissions for projects across all aspects of drug development or manufacturing lifecycle.Maintenance of the expansive combination of CMC product information, market registration details, component level dossier content and compliance of an integrated regulatory change management process to provide a comprehensive and compliant view of the CMC registered details of all products in all markets.   Assure product compliance through timely and accurate maintenance of CMC submission documentation and product knowledge in Regulatory systems.Possession of CMC regulatory knowledge and quality expertise to prepare regulatory assessments, develop & contribute to global regulatory strategies with assistance from management for projects across all aspects of drug development or manufacturing lifecycle.Continued pursuit of developing an understanding of regulatory conformance & compliance with external regulatory requirements & internal quality procedures.Execution of regulatory policies and operational processes.Actively contribute to cross-functional and strategic initiatives, novel concepts and solutions to address gaps and mitigate risks and improve conformance.Job Responsibilities Responsibilities include:Serve as a primary CMC representative on a core project(s) and provide CMC support for products at various stages including clinical trial application, NDA and post approval variations Ensure high quality CMC submissions in compliance with China regulations and guidelines. Ensuring all regulatory activities for assigned products is executed effectively & efficiently in compliance with external regulatory requirements & internal quality procedures.Manage regulatory issues, maintain submission information in relevant GCMC systems, tracks regulatory commitments & timelines for specific projects/products/markets with minimal supervision.Manage and Contribute to GCMC projects, initiatives & actions along with prioritizing assigned workload appropriately.Demonstrate ability to manage project activities, present and articulate issues for resolution and execute as a scientific/technical resource for assigned projects.Execute training related activities (e.g. compliance-related, HR policies…), individual development plans, participate in cross-disciplinary forums & learning opportunities, engage in Straight Talk & Listen exchanges, demonstrate & model adherence to all Pfizer behaviors & values, embrace & comply with GCMC Principles of Integrity.Develop effective relationships with local & global internal partners, e.g. GCMC, China RA, DC and PGS.Technical Skill RequirementsTechnical and/or other job-related skills:Sufficient level of knowledge in development & commercial activities and cGMP’s is required.An understanding of China, US and EU regulatory requirements & expectations and criteria for submission & approval globally.Demonstrated commitment & dedication to scientific & regulatory integrity & quality compliance.Knowledge of the CMC business as it relates to drug development, and partnering organizations and systems is desired.Demonstrated commitment & dedication to scientific & regulatory integrity & quality compliance.Good skills in written & oral communications in both Chinese and English are mandatory.Computer literacy with Microsoft Office Suite and Documentum-based applications highly desired.Skills in document manipulation and electronic document maintenance (e.g., Word, Excel, Adobe, Documentum, dossier workflow tools) and other data management tools任职资格:Qualifications (i.e., preferred education, experience, attributes)Education:BS, MS or PhD degree in chemistry, biology, or related scientific disciplines; Advanced degree is preferred.Experience:  Technical discipline with 5+  years of experience in the pharmaceutical industry with relevant technical experience (QA, Technical Services, Operations, Manufacturing or R&D) and 2+ years pharmaceutical regulatory experience are desired.Desired / Required Competencies:Decision Making·        Acts DecisivelyRisk Mgt·        Ability to recognize risks across projects and programs.·        Manages regulatory risks & ambiguous situations under direct supervision.Scientific & Regulatory Leadership·        Ability to contribute to projects or team initiatives to support short-term operational goals.·        Ability to influence at the work group project team level.Teamwork/ Collaboration·        Ability to contribute to effective teams & implement change.Aptitude for customer service, facilitation, and conflict resolution, approaching all situations with enthusiasm and integrity, despite demanding workload, technical barriers and changing deadlines and requirements.Communication·        Communication & Negotiation skills

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Senior Regulatory Affairs Manager 3518822GE医疗集团北京01-01

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

The Regulatory Affairs Manager provides subject matter expertise and leads a team within RA responsible for the registration of new products and/or marketed products and for the provision of regulatory guidance in assigned area. Will also be involved in or lead cross-functional initiatives.Essential Responsibilities :? To lead and develop effective teams, both within RA but also cross-functionally? To manage regulatory processes to ensure competitive approvals and maintenance of products.? To direct activities and manage the resources required to provide regulatory input into project teams and the registration of assigned GE Healthcare products, in accordance with business needs.? To ensure that team develop effective regulatory strategies, which meet business goals.? To provide proactive regulatory advice and expertise to other groups on a global basis? To act as liaison with external regulatory bodies, as required, to ensure appropriate input into regulatory strategy and gain rapid approval of submissions.? To monitor external environment, with a view to influencing changes to the benefit of the business and adapting regulatory strategies proactively? To develop and implement complex influencing and negotiating strategies which demonstrate political awareness. To drive change, challenge the status quo and champion new activities, stimulating others to change and manage implementation effectively.? To continuously review and put strategies in place to improve existing processes and champion implementation of new initiatives, both within RA and cross functionally? To proactively identify issues and problems, identify and assess risk and the chances of regulatory success, and offer solutions and recommendations on product/project issues. Make decisions under conditions of uncertainty.? To manage the recruitment, development and training of each member of their team.? To deputise for the Regulatory Affairs Director as required.The incumbent will have autonomy within the defined role. Decision making responsibility will be defined by the tasks at hand and the business implications of those decisions, including maintenance and tactical level business implications. Where decisions have strategic business implications, these will require approval by the Regulatory Affairs Executive. The incumbent will be expected to interact with all functions within GE healthcare medical diagnostics as necessary. The incumbent will be expected to interact with external contacts as necessary including maintenance and tactical level communications with Regulatory Authorities. Strategic communication may take place following agreement from the Regulatory Affairs Executive.Quality Specific Goals:1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position2. Complete all planned Quality & Compliance training within the defined deadlines3. Identify and report any quality or compliance concerns and take immediate corrective action as required4. Maintain an up-to-date knowledge and understanding of current regulatory requirements within area of responsibility, including pharmacovigilance requirements5. Maintain an understanding of the GEHC SOPs, relevant Pharmacovigilance SOPs, Working Practices and Good Regulatory Practice guide within area of responsibility任职要求:Qualifications/Requirements :1. Bachelor’s Degree/College or university education to at least first degree in a scientific discipline and a minimum of 7-10 years experience in Regulatory Affairs within the pharmaceutical industry. A considerable amount of this experience should have been gained in a senior role in the area relevant to their position, and should include global experience.2. Demonstrated ability to form, lead and manage cross-functional, cross-business teams.3. Demonstrated experience interfacing with local & international regulatory bodies, such as FDA, European competent authorities & notified bodies, Health Canada, SFDA, KFDA, MHLW, etc., including negotiation of approvals, resolution of issues and influencing/lobbying directly and through other external groups e.g. trade associations4. Ability to prioritize, plan & evaluate deliverables to established strategic goals.5. Demonstrated experience operating in a highly regulated environment; Proven application of analytical skills in a regulatory environment6. Excellent verbal and written communication and presentation skills with the ability to speak and write clearly and convincingly in English, tailoring communication methods to customer’s requirements.7. Prior experience using spreadsheet and presentation software8. Must be willing to travel up to 30% of time.Desired Characteristics :1. Advanced degree in scientific, technology or legal disciplines.2. Regulatory Affairs Certification (RAPS).3. Demonstrated experience interfacing with the Food and Drug Administration.4. Knowledge of Quality Management Systems (QMS)5. Ability to work across cultures/countries/sites6. Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment.7. Strong problem solving and negotiation skills8. Ability to work well independently & in a team setting.9. Demonstrated ability to drive change, challenge the status quo and champion new activities, stimulating others to change and manage implementation effectively.10. Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on GEHC regulatory strategies.

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Sr. RBI & Automation Director拜耳医药保健有限公司北京12-31

学历要求:硕士|工作经验:10年以上|公司性质:合资|公司规模:500-1000人

YOUR TASKS AND RESPONSIBILITIES Lead and direct the Business Intelligence and Automation team to: 1. further develop, establish and maintain an integrated tracking data base system within an integrated system landscape containing key data on regulatory events and the documentation submitted in each country, 2. operate - based on development and product strategy - a global tracking system and provide the related reporting and business intelligence capabilities, provide RA data to effectively run the RA business and keep RA business compliant with requirements of Health Authorities; ensure compliance reports for the submission of safety related documents to Health Authorities and necessary follow-up activities, 3. provide the RA contribution for Product Quality Reports to Product Supply; support global change management activities within RA; 4. ensure close cooperation with other ISY teams in the data-systems-process matrix structure, 5. ensure global communication (across functions and locations) for tracking regulatory processes and issues; develop a support network and provides training for users of the tracking system, 6. focus on opportunities for automation of existing systems and processes to increase efficiency. WHO YOU ARE Requires Ph.D., Pharm D, or equivalent scientific degree with 8 years pharmaceutical industry experience (preferably within development functions) including 5 years of relevant experience in RA or related function. Or MS degree in life sciences with 10 years pharmaceutical industry experience (preferably within development functions), which includes 7 years of relevant RA experience. ? Fluent in English and in another language, preferably German. ? Excellent oral and written communication skills. ? Well developed management and leadership skills, as incumbent has to Iead multidisciplinary teams. Demonstrated cross-functional communication, interpersonal, influence, and negotiation skills. ? Ability to focus on multiple issues at one time, and to organize and direct diverse activities in a changing environment often under time pressure incumbent must be able to work focused and target oriented in a complex scientific I technical environment. Ability to harmonize and reconcile competing objectives to achieve the overall objectives. ? Thorough knowledge of company policies and procedures in drug development and maintenance. ? Ability to work within a global team framework and a multi-cultural environment. ? The job holder must be able to absorb large amounts of information efficiently. ? The position requires scientific and technical expertise, including the ability to develop robust communication strategies, timelines and action plans.

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(ID227381)临床注册总监上海任仕达人才服务有限公司北京80-100万/年12-30

学历要求:硕士|工作经验:5-7年|公司性质:外资(欧美)|公司规模:150-500人

国内集科研、开发、生产、销售于一体的高科技生物制药企业,产品技术属于行业前沿,发展快速。业务遍及世界多个国家,并且在当地设有办公室。 企业文化好,注重员工关爱,员工福利丰富。岗位职责:1、负责组织安排公司生物药品研发项目的注册申报工作,申报资料的撰写、审核、整理和递交工作;2、负责项目CDE审评状态跟进及资料发补等工作;3、负责在研品种、公司关注品种的申报状态及相关信息的跟踪;4、负责收集政策法规、技术要求的动态信息,掌握相关产品注册方面的信息,为管理决策层提供法规意见,并对内提供相关培训;5、负责与CNDA、CDE、中检院等国家职能部门、协会等机构建立并维护良好的公共关系;6、参与注册现场核查及项目中检院送检等;7、负责项目临床试验期间的备案及沟通交流等工作;任职要求:1、药学相关专业硕士科及以上学历;2、5年以上同岗位工作经验;有多个新药IND申报的成功经验3、熟悉并掌握药品管理及注册等相关法规及技术指导原则,了解国家药品注册法规和指南;4、熟悉药品注册申报流程和各个环节,熟悉申报资料的撰写及具有对申报资料审核的能力;5、较强的药品注册信息检索和分析调研能力,良好的项目运作能力,具有解决问题的经验和思路;6、有创新药pre-IND meeting和IND申请注册经验的成功经验7、有国际注册经验的优先考虑

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高级注册经理拜耳医药保健有限公司-健康消费品事业部北京12-30

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:500-1000人

工作职责 Lead GI and Pain regulatory group and work with global regulatory teams and local cross functional teams to ensure the submission of license applications on time, and the assessment of the impact on products along with regulatory environment changes.Interpret the latest regulatory requirements and determine regulatory strategies to obtain license registration and renewal approvals.Work with both local and global regulatory team members to ensure products documents are complete, accurate and consistent with Chinese regulatory requirements and Bayer's internal quality management system.Ensure team members' compliance with all applicable regulations and Bayer's policies.Provide regulatory affairs support during internal and external audits.Stay current with the latest new regulatory policies on drugs, Health food, Food, medical devices in China.Actively participate different industry regulatory associations related to current business and influence policy changes and development in China.Develop local external regulatory KOL network and maintain constructive relationship with China regulatory bodies to enhance regulatory intelligence and overall regulatory approval rate.Develop talents and team competences on drugs, Health food, Food, medical devices.Provide coaching and mentoring to junior regulatory associates. 任职要求 More than 10 years of proven track record of regulatory experience with broad business exposure in the pharmaceutical industry. Past working experience in China is mandatory, preferably in the pharmaceuticals industry, OTC market. Consumer and market insights are essential. A good understanding of international corporate culture is helpful.Bachelor or above degree of pharmaceutical, medical, chemistry, or related life-science discipline;Well understand China registration policies and procedure on drugs, Health food, Food, medical devices etc., good relationship with governmentsExcellent communication skills, verbal and written, and strong analytical skills are required.Demonstrated leadership and project management skills, including cross-functional communication, interpersonal and influence-management skillsAbility to knowledgeably discuss and effectively deal with issues such as product safety and drug regulation compliance with internal and external strategic partners.Fluent English in verbal and written; good computer skill.

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资料排版专员华润双鹤药业股份有限公司北京-朝阳区6-8千/月12-22

学历要求:大专|工作经验:1年|公司性质:上市公司|公司规模:10000人以上

岗位职责: 1、负责药品注册资料的排版工作; 2、负责对资料进行图文排版,格式调整等工作,以达到申报要求; 3、在注册经理的指导下,负责资料整体版式的确认。 任职要求: 1、大专以上学历; 2、有排版经验或药学相关专业者优先; 3、能够熟练使用Word、PPT、Excel、Photoshop、AdobeAcrobat等办公软件; 4、善于学习,责任心强,具有团队合作精神及良好的沟通能力; 5、工作细致,承压力、执行力强。

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知名外资医药公司 - 注册经理 RA Manager万宝盛华企业管理咨询(上海)有限公司北京4-5万/月12-20

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:500-1000人

Summary of Job Responsibilities:1.      Lead regulatory strategy development and submission activities for assigned R&D projects in one TA    2.      Represent RA and provide regulatory strategy input for China compound teams; execute CTA & NDA/BLA filings; lead CDE consultation preparation activities and meeting minute’s preparation.    3.      Ensure timely Regulatory filings and response to HA queries for R&D portfolios    4.      Provide mentoring and coaching to junior staff members    5.      Establish strong relationship with regulatory authority and key stakeholders in the local, regional and global organizationDimensions of Job:1. Regulatory strategic support for assigned R&D projects including registration pathway and acceleration strategy 2. Regulatory strategy input to R&D functions and China compound teams 3. Liaise with Regulatory agency 4. Regulatory process development & resource planning    Principal Accountabilities of Job:1.Collaborate with global, regional and local product teams to develop and implement registration plan and regulatory strategy.2.Oversees regulatory activities & review critical submissions for assigned R&D projects.3.Ensure timely Regulatory submission and team response efforts to HA request.4.Lead cross-functional preparation for CDE consultation meetings.5.Interact with HA review divisions.6.Actively lead or involve in review and revision of regulations, guidelines.7.Develop internal regulatory process for effective operation.8.Credo based behavior with regulatory compliance excellence.         Qualifications & Competencies: 1.    Bachelor’s or above degree in chemistry, pharmaceutics, biology or a related life-science discipline. Advanced degree is preferred.  2.    Minimum of 5-8 years regulatory affair experience in a multinational pharmaceutical company. At least 2 years’ experience in managerial role is preferred.  3.    Strong oral & written communication skill; Strong leadership capability and ability to work under pressure.  4.    In-depth knowledge of regulatory environment, regulations and guidelines. Experience in HA interactions and pharmaceutical product registration.  5.    Ability to communicate regulatory plan and strategy to local teams. Experience in working in project teams and/or a matrix organization.  6.    Proficiency in verbal and written English; good computer skill, good presentation skill.             

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500强美资药企-药品注册万宝盛华企业管理咨询(上海)有限公司北京-朝阳区1-1.5万/月12-20

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

General operation related: 1. Help to drive operational improvements including development and use of Technology-enabled analysis and reporting tools on RA Operational Excellence, including archiving of regulatory intelligence, archiving of registration documents, SOPs learning related tracking, and other data visualization tools. 2. Proactively monitor and screen draft and final legislation, regulations, guidelines and other information on drug development and regulatory matters issued by the Health Authorities and provide updates to team timely. 3. Support the work cross-functionally with key stakeholders within Gilead organization and beyond (e.g., PVE, QA, CO, Medical Affairs, and GRA Policy etc.) for regulatory policy commenting and tracking. 4. Provide executive-level staff support in the preparation of Regulatory Intelligence Round-Up Reports and RI Alerts. Products related: 5. Support the RA PL on Labeling & Artwork related review on RA projects. 6. Support the RA PL to maintain product summary list 7. Support the RA PL for the preparation and collation of the submission package documents including tracking translation and basic reformat adjustment while the application is filing. n Professional Experience / Key Skills 1. At least a BSc degree or equivalent is required (MSc preferred) with at minimum of 1+ years of experience in regulatory affairs or Drug R&D work. 2. Working experience in a regulatory affairs department is preferred or have the basic knowledge of current China regulatory environment. 3. Affinities for using new and novel technologies for enhanced efficiency and achieve operational objectives. 4. Good communication skills, verbal and written, are imperative. 5. Good English skills, oral and written.

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药品注册专员华润三九医药股份有限公司北京-朝阳区0.8-1万/月12-11

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

岗位职责:1、按照公司目标,制定申报计划,完成所负责新药的国内或国际注册工作,包括IND/CTA,NDA/BLA等,并负责跟进后续的维护更新工作;2、负责规划产品注册申请的时间与计划,负责注册申请文件资料的检索、翻译、撰写、编辑、审核和递交;3、负责与CDE等部门联系沟通,确保各个注册申请的报送、审评和审批的顺利进行,实时跟踪产品注册进程,协助解决注册过程中出现的各种问题;4、掌握NMPA/FDA对申报资料的要求,提供法规支持,协助解决研究过程中遇到的问题;5、及时汇总、分类、整理、归档NMPA/FDA等药监部门出台的各项药事法规、文件、技术指导原则,为公司决策提供建议;6、负责对现有项目的日常维护、资料更新、文献检索翻译等工作,妥善保管药品注册文件;7、建立并保持政府部门之间良好的关系;8、完成上级交办的其他工作。任职资格:1、本科及以上学历,生物学、药理学、药学或者临床医学专业;2、三年以上注册工作经验,能独立开展相关工作,具有成功申报经验者优先;3、熟悉CFDA、FDA和EMA等国家或地区的注册法规指南及药品注册流程;4、熟悉CTD、eCTD格式申报资料的撰写要求;5、具有良好的中文文字表达能力及扎实的文字撰写功底;6、具备优秀的沟通表达能力、团队协作,工作责任心强,细致严谨。所属业务单元:华润三九处方药事业部 – 北京华润北贸医药经营有限公司华润三九处方药事业部,以“解决治疗需求”为使命,对内以“专业,专注,进取”为核心价值观持续转型升级,对外开展多元化合作不断夯实管线布局,致力成为国内处方药细分领域(消化、骨科、心脑重症、肿瘤等)强有力的竞争者。

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