Associate Director, Regulatory Affairs

of the job: Manage regulatory aspects of compounds through all phases of development until around one year after marketing. Regulatory Strategy Development and Implementation: developing, implementing, and advising on China regulatory strategies, including regulatory strategies, regulatory requirements for clinical studies and marketing approval in domestic, regulatory strategic development plans and risk assessments, critical issue management and advice on Health Authority interactions. Provide leadership and strategic regulatory oversight for designated projects ensuring that the latest requirements, standards and timeline are met. Review sections of IND/CTA/CTN, BLA/NDA/MAA, Life cycle management and other global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements. Communication with Regulatory Authorities: Liaises and negotiates with China regulatory authorities as needed for all aspects of drug development including resolution of key regulatory issues and to expedite approvals. Interface with business partners regarding regulatory registration strategies if needed. AND/OR Manage regulatory aspects of compounds through all phases of development until around one year after marketing. Manage regulatory aspects of compounds after marketing and maintain the life-cycle management in China. Provide leadership and strategic regulatory oversight for designated projects ensuring that the latest requirements, standards and timeline are met. Review sections of variations, and other submission documents in support of post-marketing applications, in conformance with local regulatory requirements. Liaises and negotiates with regulatory authorities as needed for all aspects pertaining to life-cycle maintenance including resolution of key regulatory issues and to expedite approvals of product and labeling changes, etc. Interface with business partners regarding post-marketing regulatory strategies. Maintain awareness of the global regulatory environment and assess the impact of changes on business and product development programs. As part of the policy and development of the standard interpretation of China regulation and policy shaping in China. Contribute to the policy and development of the standard interpretation of China regulations internally Integrates RAS expertise with business knowledge to solve project problems Builds partnerships with key project stakeholders to ensure that strategic business goals are met Manages critical issues related to responsible projects with supports from LM or experienced SMEs during solution exploring if any Core Competencies, Knowledge and Skill Requirements: Over 8 years working experience in regulatory affairs; and working experience in international company is preferred Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends. Experience and knowledge in preparation of INDs and NDAs, and supportive amendments and supplements (manufacturing, nonclinical, clinical). Experience for new drug development strategic planning and cross-functional project coordination is a plus. Experienced with CTD/eCTD. 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. Be detail-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment. Communication & Interpersonal Skills: Excellent oral and written communication skills. Could take the Influence and Advisory Role within Regulatory strategies team: Exerts influence at the regional levels, serving as an advisor/liaison to CRA team to plan, evaluate, and recommend regulatory strategies. Excellent Regulatory Cross-team Collaboration Leadership: Builds close partnerships with the cross CRAS team to ensure project strategic goals are met through shared knowledge and expertise. Good command of written and oral English and Mandarin Interaction with BeiGene employees and senior management. Interaction with external business partners and Regulatory Agencies 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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, standards and timeline. This role will integrate RAS expertise with business knowledge to solve complex project problems and build partnerships with key stakeholders to meet strategic business goals.