Job Description

工作地点：连云港/苏州（优先连云港）

主要职责

Job Responsibilities:

根据产品临床研究进展，独立制定药品注册全周期策略和药学研发注册计划，保证药学研发和申报能够匹配临床开发和注册申报上市要求，并有效地组织和协调资源，确保项目按时完成

Establish Pharmaceutical Development Plan (PDP) and Chemical, Manufacture and Controls (CMC) regulatory strategy according to the clinical development progress (CDP), ensure that pharmaceutical development and regulatory filings are aligned with the requirements of clinical development and marketing authorization application, and effectively organize and coordinate resources to guarantee the timeline of each regulatory activities.

统筹注册项目进度，协调研发、生产、质量、临床等内部团队及 CRO 等外部机构，确保申报资料按时、合规准备，监控项目风险（如法规变更、技术要求更新），及时调整策略，推动注册流程顺利推进

Oversee the overall progress of projects, coordinate internal teams (including R&D, manufacturing, quality, and clinical teams) and external entities such as CROs, ensure the timely and compliant preparation of regulatory filing documents, monitor project risks (e.g., policy updates, updates to technical requirements), promptly adjust strategies, and facilitate the smooth progression of the regulatory registration process.

编写注册申报资料，确保内容符合法规及技术指导原则要求。审核研发、生产等部门提供的技术资料，确保数据完整性、科学性及合规性

Prepare the registration dossier to ensure that the contents comply with the requirements of regulations and guidelines. Review the technical doc and data provided by CMC R & D, production and other departments to ensure data integrity, scientific and compliance.

负责监管沟通，包括及时回复监管机构的疑问或补充资料要求，组织各类药学沟通会

Responsible for Agency communications, including timely response to queries or supplementary information required from regulatory authorities, and organizing CMC related meetings with Agency.

跟踪国内外注册申报政策、法规及技术指南更新（如 NMPA、FDA、EMA 等机构动态）以及产品相关技术文献和专利，整理解读报告，为研发团队提供参考。

Track the updates of policies, guidelines (e.g., NMPA, FDA, EMA, etc.), as well as product-related technical literature and patents, collate and interpret the report to provide reference for the CMC R&D and RA team.

任职资格与能力要求

语言：良好的英语写作和口语交流技能，可熟练运用作为工作语言。

Good English writing and oral communication skills as the working language.

学历与专业：

硕士或博士学历，博士优先；化学，生物学、药学等相关专业

Master or PhD, PhD preferred; major in Chemistry, Biology, Pharmacy, etc.

知识与技能：

了解药品申报基本流程，熟悉药品等核心法规者优先

Understand the drug application procedure, being familiar with pharmaceuticals regulations is preferred.

具备较强英语听说读写能力，英语可以作为工作语言

Possess strong English listening, speaking, reading and writing skills, with English serving as a working language.

具备文档编制与审核能力，熟练使用 Office（Word/Excel/PPT）、PDF编辑工具（如 Adobe Acrobat）

Documentation and review capability, proficient in Office (Word/Excel/PPT), PDF editing tools (e.g., Adobe Acrobat).

能力要求：

具备较强的学习能力，能快速学习了解行业新技术要求，适应监管政策变化

Exhibit advanced learning agility, enabling the rapid absorption of complex industry technical demands and the ability to anticipate regulatory policy trends, thereby adjusting long-term work strategies to align with organizational and regulatory objectives.

细致严谨，对数据与文档的准确性有高敏感度，能规避申报资料中的合规风险

Be detail-focused and rigorous in work execution, maintain heightened sensitivity to data and document accuracy, and take effective measures to minimize compliance risks related to application dossiers.

具备良好的沟通协调能力，能高效对接内外部团队，推动问题解决

Good communication and coordination skills, able to effectively dock internal and external teams, and promote problem solving.

有责任心，能承受一定的项目 deadlines 压力，具备团队协作意识

Responsible, able to withstand certain deadlines pressure of the project, and have a sense of teamwork.

有明确的职业规划，愿意长期在注册申报 / 合规领域发展

Possess a clear career roadmap and is dedicated to long-term professional growth within the domain of regulatory registration and compliance.

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