(Sr.) RA Manager, Beijing

3 months ago


Beijing, China Takeda Full time

Description

In accordance with the company’s product launch strategy and department’s work plan, take full responsibility of the product registration and application for approval and develop the plan by stage. Contribute to decision making on drug registration leading to minimal registration timeline. May lead a project team or initiative within department or cross-functions/divisions. Provides technical leadership to business. Summarize product registration related materials with coordination among head office, factory, Sales & Marketing. Provide corresponding support for the sales in China market. In accordance with the plan of product registration and application for approval, manage the necessary materials and information during the process and track and summarize the progress. Be responsible for submission of complete and qualified product application data to drug regulatory authorities, coordination of raw data review and on-site assessment. Manage and archive examination and registration materials and other relevant documents. Provide necessary support to the preparation and implementation of clinical trial. Establish influential relationships with key regulatory authority individuals and KOLs in relevant fields, such as SFDA, CDE, NIFDC, PIDC etc. Monitor regulatory environment and collect important information such as regulations, guidelines, competitive products etc. Establish and maintain internal/external channels of communication. Ensure regulatory activity is in compliance with authority and Takeda policy. Coordinate with the establishment of internal SOP and system. Others assigned by line manager.

Qualifications & Skills:

Level of Education: Bachelor’s degree or above majored in medicine or pharmacy. Working Experience in Relevant Field: > 7 years related work experience Professional Knowledge and Skills: Skilled in using computer office software. Good English or Japanese in listening, speaking, reading and writing. Be familiar with the laws and regulations of drug administration and registration management, stronger professional competency, excellent communication skill and leadership. Teamwork and collaboration.

Locations

CHN - Beijing - Research and Development

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
  • Associate RA Manager

    6 months ago


    Beijing, China Bayer Full time

    At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...


  • Beijing, China Bayer Full time

    At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...


  • Beijing, Beijing, China Western Academy of Beijing Full time

    Job Summary:We are seeking a highly skilled Facilities Management Specialist to join our team at the Western Academy of Beijing. This is an exciting opportunity to work in a dynamic and fast-paced environment, where you will be responsible for overseeing the maintenance and upkeep of our facilities.About Us:The Western Academy of Beijing is a world-class...


  • Beijing, China Amazon (China) Holding Company Limited Full time

    About Amazon.com Amazon.com strives to be Earth's most customer-centric company where people can find and discover virtually anything they want to buy online. By giving customers more of what they want - low prices, vast selection, and convenience - Amazon.com continues to grow and evolve as a world-class e-commerce platform. Amazon's evolution from Web site...

  • Sr. Project Manager

    2 months ago


    Beijing, Beijing, China Thermo Fisher Scientific Full time

    OverviewThermo Fisher Scientific is seeking an experienced Sr. Project Manager to lead cross-functional project teams and drive the successful delivery of projects.Key ResponsibilitiesLead and manage cross-functional project teams to achieve project goals and objectivesDevelop and execute project plans, including timelines, budgets, and resource...


  • Beijing, China Lenovo Full time

    Description and Requirements Role and Responsibility Responsible for in-depth research on cutting-edge large model technologies such as RAG, prompt and agent, exploring innovative large model expansion applications. Responsible for multi-modal large model technology selection, guiding CV algorithm pipeline work. Work closely with teams such as...


  • Beijing, Beijing, China Four Seasons Hotels and Resorts Full time

    About Four Seasons Hotel Beijing:As a world-class luxury hotel, Four Seasons Hotel Beijing is seeking a seasoned Hotel Manager to lead our team. Our hotel is a sanctuary of refinement, style, and highly personalized service, offering an unparalleled guest experience in the heart of Beijing's dynamic business and residential area.About the Job:The successful...

  • Sr. Product Manager

    7 months ago


    Beijing, China Bayer Full time

    At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...


  • Beijing, Beijing, China 0910 Deutsche Bank (China) Co., Ltd., Beijing Branch Full time

    Job OverviewWe are seeking a highly skilled Cash Management and Trade Finance Expert to join our team at 0910 Deutsche Bank (China) Co., Ltd., Beijing Branch. This role offers an exciting opportunity to work in a dynamic environment, driving business growth and delivering exceptional client experiences.About the RoleThis position is responsible for...


  • Beijing, China Hyatt Corporation Full time

    Duty Manager-Grand Hyatt Beijing Grand Hyatt Grand Hyatt Beijing CN - 11 - BeijingFront OfficeEntry Level ManagerFull-timeReq ID: BEI001958Local Summary You will be responsible to assist with the efficient running of the department in line with Hyatt Hotels Corporation's Corporate Strategies and brand standards, whilst meeting employee, guest...


  • Beijing, Beijing, China Goldman Sachs Full time

    At Goldman Sachs, we are seeking a highly skilled Risk Management Associate to join our team in Beijing. As a key member of our Internal Audit department, you will play a critical role in ensuring the effectiveness of our firm's risk management practices.The ideal candidate will possess strong analytical and problem-solving skills, with the ability to think...


  • Beijing, China Takeda Full time

    Description 职位目的 根据公司整体业务目标和营销策略,以及所在市场的销售计划及指标,制定并实施辖区的销售计划,有效地管理客户及公司资源,提高人均产值,实现辖区销售任务,帮助公司实现预期的经营目标。 主要职责 ...


  • Beijing, Beijing, China Amazon Connect Technology Services (Beijing) Co., Ltd. Full time

    About the RoleWe are seeking a highly motivated and customer-obsessed professional to join our team as a Security Operations Cluster Manager at Amazon Web Services in Beijing.Job DescriptionThe ideal candidate will have 7+ years of experience managing contract security and physical security operation programs, with a focus on access control, intrusion...


  • Beijing, Beijing, China Hyatt Corporation Full time

    About This RoleWe are seeking a skilled Facilities Maintenance Manager to join our team at Grand Hyatt Beijing.Job SummaryThis is an exciting opportunity for a motivated and experienced facilities maintenance professional to lead our engineering department in ensuring the efficient and economic operation of our facilities.Key ResponsibilitiesAssist the...


  • Beijing, China Takeda Full time

    Description RESPONSIBILITIES 1. Cooperate with business units to develop medical marketing strategy and 1-3 years of business plan. 2. Perform medical review of promotional materials for Takeda product portfolio to ensure high brand quality from scientific and ethical point of view. 3. Provide cross-functional medical coach and support for product...


  • Beijing, China Takeda Full time

    Description : 1. 分析分管产品的市场竞争状况、准备针对性的营销工具,为高销售团队对分管产品的了解做准备。 2. 分析分管产品的市场销售趋势,为销售团队制定销售指标提供参考依据。 3....


  • Beijing, Beijing, China BEJ Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Full time

    About UsBEJ Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd is a leading global contract research organization with a passion for scientific rigor and decades of clinical development experience.Company OverviewWe provide pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and...


  • Beijing, Beijing, China Stryker (Beijing) Healthcare Products Co. Ltd Full time

    About UsStryker (Beijing) Healthcare Products Co. Ltd is a leading global medical technology company dedicated to helping healthcare professionals improve patient outcomes.Salary and BenefitsThe estimated annual salary for this position is approximately RMB 600,000 - RMB 900,000 depending on experience and qualifications. In addition to a competitive salary,...

  • Auditor (Beijing)

    6 months ago


    Beijing, China Swire Full time

    Swire (Beijing) Management Consultancy Limited The Swire group is a multi-national, multi-disciplined commercial group, with its principal areas of operations in the Asia Pacific region and centred in the Greater China area. Our name 太古 or Taikoo, means 'Great and Ancient', and our headquarters is in the United Kingdom.  In Asia, our business...


  • Beijing, Beijing, China Pfizer Full time

    Job SummaryPfizer is seeking an experienced Regional Business Development Manager to lead our business development efforts in the Beijing region. As a key member of our team, you will be responsible for driving growth and revenue through strategic partnerships, collaborations, and negotiations.About the RoleThis is a senior leadership position that requires...