Associate Manager, Regulatory Affairs, COE

General Description: BeOne is seeking an energetic person who can provide regulatory support for all registration related projects This individual will be responsible for timely support line-manager of regulatory submissions, registration follow up, HA meeting preparation, lab testing and on- site inspection etc. This individual will also be responsible for clearly delivering regulatory requirements to cross-functional team to make sure them understand the regulatory requirements clearly. Keep closely follow up regulations update and conduct the consultation if necessary. Essential Functions of the job: Responsibilities With minimal supervision, plans and manages regulatory activities related to assigned projects that span technical areas including clinical, non-clinical, and CMC. Assists with developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects. Manages the preparation, including writing as necessary, assembly, review, and timely submission of regulatory dossiers as required for investigation and registration of products in China and abroad. Ensures regulatory submissions are maintained in compliance with regulatory requirements. Support sand manages preparation of meeting requests and briefing documents. Manages the preparation, review, and submission of all components of regulatory submissions including INDs and amendments, BLAs/NDAs and supplements, annual reports etc. Participates in project teams and provide expertise on regulatory matters. Closely follows up registration projects progress, keeps the line-manager and cross-functional team updated. Develops and maintains current regulatory knowledge and advises management of significant developments. Supports regulatory archive. Works with external regulatory consultants/CRO’s as required. Core Competencies, Knowledge and Skill Requirements Over 3 years working experience in regulatory affairs. And working experience in international company is preferred. Experience and knowledge in preparation of INDs (required) and NDAs (desirable), and supportive amendments and supplements (manufacturing, nonclinical, clinical). Understanding of NMPA structure and function. Knowledge of/experienced with regulatory requirements for other regions also desirable. Working knowledge of GMP, GLP, and GCP regulations and an understanding of the pharmaceutical product life cycle. Excellent oral and written communication skills are must, as well as superior planning skills. The candidate should be detail-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment. Communication & Interpersonal Skills Excellent interpersonal communication skills. Good command of written and oral English and Mandarin Interaction with BeiGene employees. Interaction with external business partners and Regulatory Agencies Education Required: BA / BS in Health Sciences preferred, with at least 3 years’ experience in the pharmaceutical industry Computer Skills : Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint) Travel: Must be willing to travel approximately 10-20% Ability to work on a computer for extended periods of time 百济神州全球胜任力 当我们通过以下十二项全球胜任力，展现出 "患者为先"、"无界协作"、"锐意创新 "和 "追求卓越 "的价值观时，我们就能帮助全世界更多患者获得更多负担得起的药品。 ●团队协作 ●提供并征求坦诚及可行的反馈 ●自我认知 ●兼容并蓄 ●积极主动 ●开拓精神 ●持续学习 ●拥抱变化 ●结果导向 ●分析性思维/数据分析 ●卓越财务 ●清晰沟通 BeOne Global Competencies When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. ●Fosters Teamwork ●Provides and Solicits Honest and Actionable Feedback ●Self-Awareness ●Acts Inclusively ●Demonstrates Initiative ●Entrepreneurial Mindset ●Continuous Learning ●Embraces Change ●Results-Oriented ●Analytical Thinking/Data Analysis ●Financial Excellence ●Communicates with Clarity 求职者隐私申明： 百济神州致力于尊重和保护您的个人信息权利，并承诺依据合法、正当、必要和诚信的原则处理您的个人信息（包括个人敏感信息 ）。 由于百济神州在全球范围内开展业务，我们可能需要基于人力资源管理等合理业务目的而将您的个人信息发送和/或存储在位于您所在国家以外其他国家（例如：美国）的服务器和数据库中，详情参见百济神州《求职者隐私政策》（百济神州官网 - 隐私政策 - 求职者隐私政策）。 如您主动向我们提供您的简历信息或其他个人信息，则视为您已经充分理解并确认接受百济神州《求职者隐私政策》内容。如您对此有任何疑问的，请勿提交简历信息或其他个人信息。 BeOne is committed to respect and protect your personal information rights, and will process your personal information, including your sensitive personal information, based on the principles of legality, legitimacy, necessity, and integrity. 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