工作地点：

香港特别行政区

工作职责：

主要职责定位Major Duties and Responsibilities Summary:
生物制品全链条技术研发后端核心研发岗位，面向香港卫生署及海外药监/合作方，参与生物制品研发策略讨论与制定、临床研发设计与合规、多区域注册技术攻关，支撑香港子公司生物医药研发项目实质性运营，为公司产品在港及全球获批上市提供技术研发输出。

For core R&D positions in the post‑stage of the full‑chain biopharmaceutical technology development, with a focus on engaging with the Hong Kong Department of Health, overseas regulatory authorities, and collaborative partners. Responsibilities include participating in the discussion and formulation of biopharmaceutical development strategies, clinical development design and compliance, and technical problem‑solving for multi‑regional registration. The role supports the substantive operation of biomedical R&D projects at the Hong Kong subsidiary, providing technical R&D outputs to facilitate the company's product approvals and market launches in Hong Kong and globally.

主要职责Major Duties and Responsibilities
1、（前沿跟进和问题处理）密切跟踪国际产品开发的最新动态和前沿知识，按要求承担相关工作的落实，及时发现执行过程中出现的重大问题并协调处理。跟踪香港及全球药监法规更新，完成法规差距分析、内部研发合规培训，维护产品注册技术档案全生命周期管理，支撑香港本地研发项目稳定运营。
2、（注册及临床开发策略与决策支持）对现行主要市场药品注册的相关法律法规及有关药物研究指导原则进行深入研究，制定公司产品注册及临床开发策略，提供高水平决策支持，并推动实施符合公司长期发展战略的产品开发策略。
3、（临床资料准备）负责公司产品在香港卫生署、以及 EMA、FDA 等海外药监机构的药品临床申报及上市注册全流程技术工作，牵头注册资料撰写、模块整合、数据汇总与技术方案与报告审核，并指导研发策略修改优化。基于香港《药剂业及毒药条例》、香港药品注册技术指导原则，开展注册路径研判、临床方案撰写讨论及法规符合性评估、临床研究数据桥接论证、标签及说明书合规拟定，反向指导产品生产工艺、质量标准与非临床研究优化。
4、（支持临床运营）参与香港本地临床试验机构对接、伦理递交、试验物料合规流转管理，推动临床试验在港落地实施。统筹研发用临床批次、参比样品、稳定性留样跨境进口合规管理。
5、（注册项目管理与推进）独立或牵头管理临床申报项目，制定申报计划并推动实施，确保项目按时完成，协调研发、生产、质量、临床及外部合作方等多方资源，保障项目顺利推进，跟踪临床审批进度，及时反馈监管机构意见，并组织内部应对，识别项目风险并提出解决方案，确保注册路径可行性和合规性。
6、（监管沟通与外部关系管理）对接香港卫生署审评沟通、发补答复、现场核查准备，处理审评问询与缺陷回复，组织注册相关的内外部会议，推动关键问题解决，建立并维护与监管机构及行业专家的良好沟通关系，跟进现场核查、检验及技术审评过程，协调资源确保顺利通过。
7、（国际化与语言能力应用）在多语言环境中有效工作，确保所有注册材料的翻译准确无误，并在与各国合作方及监管机构的沟通中展现出色的书面及口头语言表达技能，保障信息的顺畅交流和准确传达。
8、根据需求配合各部门研发工作。
1. (Frontier Tracking & Issue Resolution) Closely track the latest developments and cutting-edge knowledge in international product development; implement relevant work as required; promptly identify major issues arising during execution and coordinate their resolution. Track regulatory updates from Hong Kong and global health authorities; conduct regulatory gap analysis and internal R&D compliance training; maintain full-lifecycle management of product registration technical dossiers, supporting the stable operation of local Hong Kong R&D projects.
2. (Registration & Clinical Development Strategy and Decision Support) Conduct in-depth research on current drug registration laws, regulations, and drug research guidelines in major markets; formulate company product registration and clinical development strategies; provide high-level decision support; and drive the implementation of product development strategies aligned with the company's long-term development goals.
3. (Clinical Submission Preparation) Responsible for the full-process technical work of clinical trial applications and marketing registration for the company's products with the Hong Kong Department of Health, as well as overseas regulatory agencies such as EMA and FDA. Lead the drafting of registration dossiers, module integration, data compilation, and review of technical protocols and reports; guide the modification and optimization of R&D strategies. Based on Hong Kong's Pharmacy and Poisons Ordinance and Hong Kong drug registration technical guidelines, conduct registration pathway assessment, clinical protocol drafting, discussion and regulatory compliance evaluation, clinical study data bridging justification, and compliant drafting of labeling and package inserts; provide reverse guidance for optimizing product manufacturing processes, quality standards, and non-clinical studies.
4. (Support for Clinical Operations) Participate in liaising with local Hong Kong clinical trial institutions, ethics submissions, and compliant management of trial material circulation; drive the implementation of clinical trials in Hong Kong. Oversee the compliant cross-border import management of R&D clinical batches, reference samples, and stability retention samples.
5. (Regulatory Project Management & Execution) Independently or lead the management of clinical trial projects; develop regulatory plans and drive their implementation to ensure on-time project completion; coordinate resources across R&D, manufacturing, quality, clinical, and external partners to ensure smooth project progression; track clinical approval progress, provide timely feedback on regulatory agency opinions, and organize internal responses; identify project risks and propose solutions to ensure the feasibility and compliance of registration pathways.
6. (Regulatory Communication & External Relationship Management) Liaise with the Hong Kong Department of Health for scientific advice communication, responses to deficiency letters, and on-site inspection preparation; handle review inquiries and deficiency responses; organize internal and external regulatory-related meetings to drive resolution of key issues; establish and maintain good communication relationships with regulatory authorities and industry experts; follow up on on-site inspections, testing, and technical review processes, and coordinate resources to ensure successful passage.
7. (Internationalization & Language Proficiency Application) Work effectively in a multilingual environment; ensure accurate preparation of protocols, reports and dossier; demonstrate excellent written and oral communication skills in interactions with partners and regulatory authorities across countries, ensuring smooth and accurate information exchange.
8. Support R&D work of various departments as needed.

任职资格：

1.教育背景 Education：生物、药学、医药类等相关专业硕士学历及以上。Master's degree or above in Biology, Pharmacy, Medicine, or related fields.
2.工作经验 Experience ：至少7年丰富的临床申报项目管理经验和相关领域工作经验。At least 7 years of extensive experience in clinical trial application project management and related fields.
3.基本专业知识Knowledge ：熟悉生物制药基础知识，理解生物制药研发流程和临床申报要求，主导过临床申报项目。
精通疫苗相关法规与指南，如FDA、EMA、ICH、NMPA、香港卫生署等主流监管法规。精通临床申报文件的编写、整理、审核及申报流程。
对药品研发策略和市场动态有深入的了解，以确保研发工作开展的合规性和及时性。
Familiar with fundamentals of biopharmaceuticals; understanding of biopharmaceutical R&D processes and clinical submission requirements; experience leading clinical submission projects.
Proficient in vaccine-related regulations and guidelines, including mainstream regulatory frameworks such as FDA, EMA, ICH, NMPA, and the Hong Kong Department of Health. Proficient in the drafting, compilation, review, and submission processes of clinical submission documents.
In-depth understanding of drug R&D strategies and market dynamics to ensure the compliance and timeliness of R&D work.
4.通用能力素质Capability：出色的沟通和团队合作能力，能够与团队成员和其他部门有效协作。
具备自主学习和解决问题的能力，及时适应新技术和新方法。
具有道德和伦理标准，确保注册管理职责所涉及公司相关信息的安全和保密。
具备严谨的工作态度，注重细节和实操环节的合规性。
具备良好的沟通协调能力，能够与不同利益相关者进行有效的沟通协调，包括香港卫生署及各国监管机构、合作伙伴、国际客户等。
具备良好的英语读写能力，能够使用英语进行沟通，能够理解和撰写职责履行所需要的高质量实验方案、报告等重要文件。
Excellent communication and teamwork skills, with the ability to collaborate effectively with team members and other departments.
Ability for self-directed learning and problem-solving, with adaptability to new technologies and methodologies.
High ethical and professional standards, ensuring the security and confidentiality of company information related to regulatory management responsibilities.
Rigorous work attitude, with attention to detail and compliance in operational processes.
Strong communication and coordination skills, with the ability to effectively communicate and coordinate with various stakeholders, including the Hong Kong Department of Health, regulatory authorities across countries, partners, and international clients.
Good English reading and writing skills; ability to communicate in English and to understand and draft high-quality protocols, reports, and other important documents required for fulfilling job responsibilities.