高级注册经理Senior RA Manager-非肿瘤创新药-上市前

该职位来源于猎聘 资深高级注册经理（非肿瘤创新药 – 上市前） Senior RA Manager, Innovative Non-Oncology Drug – Pre-Marketing 岗位职责 / Responsibilities 1. 上市前注册管理 全面负责公司进口创新药的国内注册申报工作，统筹立项、临床试验申请（IND）、临床评估、NDA注册申报及上市前合规全流程。 Pre-Marketing Regulatory Management Overall responsible for the domestic registration of innovative imported drugs, including project initiation, IND application, clinical evaluation, NDA submission, and pre-marketing compliance throughout the entire process. 2. IND/NDA申报策略与执行 主导并完成NMPA IND/NDA注册通道的申报工作，熟练运用四条加快上市通道。负责IND前、关键临床试验启动前、NDA前等关键阶段与CDE的沟通协调，推动产品快速、合规上市。 IND/NDA Submission Strategy & Execution Lead and complete submissions under NMPA IND/NDA pathways, and adeptly utilize the four accelerated approval pathways. Manage communications with CDE at critical stages such as pre-IND, before pivotal clinical trial initiation, and pre-NDA, to drive rapid and compliant market access. 3. 跨部门协作与项目管理 与研发、临床、商务拓展/市场、质量及海外团队紧密合作，制定注册策略，识别风险节点，确保注册路径清晰可行，项目按计划推进。 Cross-Functional Collaboration & Project Management Work closely with R&D, clinical, BD/marketing, quality, and overseas teams to develop regulatory strategies, identify risk points, and ensure a clear, feasible, and timely registration pathway. 4. 注册资料系统化撰写和管理 主导CTD/eCTD格式注册技术文件的撰写、审核与归档，确保资料完整、合规、高质量。掌握eCTD申报受理通道。负责药品试验数据保护的申请与管理。 Systematic Authoring & Management of Regulatory Documentation Lead the drafting, review, and archiving of CTD/eCTD-format regulatory dossiers to ensure completeness, compliance, and high quality. Master the eCTD submission acceptance pathway. Responsible for the application and management of drug clinical trial data protection. 任职要求 / Requirements 1. 教育背景 本科及以上学历，药学、医学、生物化学、制药工程等相关专业。 Education Bachelor’s degree or above in Pharmacy, Medicine, Biochemistry, Pharmaceutical Engineering, or related fields. 2. 注册经验 5年以上创新药上市前注册经验，具备成功主导NMPA IND/NDA申报并获批的完整案例。熟悉进口创新药在中国注册的路径与常见问题，包括境外临床数据桥接策略、CDE沟通技巧、eCTD申报要求等。具有呼吸系统疾病及抗过敏药物注册经验者优先。 Regulatory Experience 5+ years of experience in pre-marketing registration of innovative drugs, with a proven track record of successfully leading and obtaining approval for NMPA IND/NDA submissions. Familiar with registration pathways and common challenges for imported innovative drugs in China, including bridging strategies for overseas clinical data, CDE communication tactics, and eCTD submission requirements. Experience with innovative drugs in respiratory diseases and anti-allergy therapies is preferred. 3. 体系能力 理解并能够建立、维护和持续优化符合NMPA、FDA要求的注册事务管理体系。具备独立搭建或主导维护创新药注册相关质量体系的能力，能够支持或主持公司内部审核及管理评审。 Regulatory System Capability Understand and be able to establish, maintain, and continuously improve a regulatory affairs management system compliant with NMPA and FDA requirements. Capable of independently establishing or leading the maintenance of a drug regulatory quality system, and able to support or lead internal audits and management reviews. 4. 语言与沟通能力 英语可作为工作语言，流畅进行技术文件编写、审评沟通、跨国团队协作。 Language & Communication Skills English proficient as a working language for technical documentation, regulatory communication, and cross-border collaboration. 5. 核心素质 出色的项目管理、跨部门沟通及复杂问题解决能力。能适应快节奏的创业型组织环境，具备Owner心态，主动推动资源与结果落地。 Core Competencies Excellent project management, cross-functional communication, and complex problem-solving skills. Able to thrive in a fast-paced, startup-like environment with an owner’s mindset, proactively driving resources and delivering results.