Regulatory Writer (Manager/Sr. Manager level）

Location:

Guangshou, Guangdong, China

Position Summary:

The Regulatory Writer (Manager/Sr. Manager level, depending on seniority) contributes to the vision and goals of Global Regulatory Affairs (GRA) by: 

Providing innovative scientific and regulatory writing and submission expertise for products in development by implementing aligned global regulatory strategies and activities for Angitia’s developmental portfolio and accountable for non-clinical, clinical and safety content in global regulatory documentation. Assuring a productive collaboration with key internal stakeholders, such as research, early and late-stage clinical development, CMC, to ensure successful development, strategic alignment and execution of global regulatory strategies that result in successful applications for Angitia’s product portfolio, from early development to Marketing Authorization (MA). 

In collaboration with GRA colleagues and vendors, supporting the establishment and maintenance of high-quality working relationships with CDE and other global regulatory agencies for Angitia. 

医学写作（经理~高级经理级别，根据候选人经验和资历确定职位级别）通过以下方式为全球注册事务团队（GRA）的愿景和目标做出贡献：   

为公司在研产品提供创新的科学和注册写作和递交，实施与全球注册策略相一致的注册策略，负责非临床、临床和安全性等内容的全球注册文件的编制。与跨部门团队（如研发、转化医学和临床开发、CMC等部门）高效协作，确保公司产品从早期开发到上市许可递交的全球注册策略的执行。   

与GRA同事和供应商合作，支持与CDE及其他全球监管机构建立和维护高质量的工作关系。

Job responsibilities 工作职责:

• Prepare regulatory submissions to CDE across a diverse portfolio of product types (small molecule, biologics, combinations), development phases, and scientific disciplines (nonclinical, clinical, general regulatory).  为多种产品类型（小分子、生物制品、组合产品）在不同开发阶段和科学领域（非临床、临床、注册等）准备提交给CDE的各类注册文件。 

• Lead the authoring and review of medical and regulatory documents with cross-function teams [CDE meeting request and package, IND/NDA modules, Clinical Study Reports, Protocols and non-Clinical study reports, etc.]. Responsible for providing advanced expertise and support to Regulatory Management in the development and preparation of regulatory documents.   领导跨部门合作，按照时间表撰写和审阅医学及注册文件（如CDE沟通交流会议申请、IND/NDA文件、临床研究报告、临床研究方案和非临床研究报告等），并为注册部门在注册文件的撰写过程中提供专业知识和支持。

• Work closely with team members in identifying and ensuring compliance with requirements for responses to request for information after major submissions to global regulatory authorities (INDs/CTAs, BLAs/NDAs).  与团队成员密切合作，确保在全球注册申报（如INDs/CTAs、BLAs/NDAs）后的信息请求回复中识别并满足相关法规要求。 

• Partner with submission manager to ensure the accuracy and quality of submission-ready documents in a timely manner, compliance of regulatory submissions to regulatory authorities and execution of regulatory strategies.与注册项目负责人合作确保提交文件的及时性、准确性和质量、及向各监管机构提交注册申请的合规性，保证注册策略的实施。

• Lead the translation of global medical and regulatory documents into Chinese or proof-read the translated documents from vendors to ensure the accuracy and quality of the contents. 领导将全球医学和注册文件翻译成中文或校对供应商翻译的文件，确保内容的准确性和高质量。   

• Understand, interpret, and share relevant guidance and where needed identify and or summarize other information sources (e.g., scientific literature, study summaries, figures, tables, graphs, health authority minutes). 分享并解读相关指南，并在需要时搜索或总结其他信息来源（如科学文献、研究摘要、图表、监管机构会议纪要等）。   

• Prepare templates, develop writing style guidelines, and facilitate efficient team contributions to provision of requested/relevant data and information. Provide expertise and guidance on document design and principles of good medical writing to the department and product teams. 准备文件模板，制定写作指南，促进团队进行符合相关监管要求的高效写作。向各部门提供良好医学写作方面的专业知识和指导。 

• Partner with regulatory and external publishers to ensure all regulatory electronic document deliverables are processed and compiled in alignment with timelines. 与注册部门和外部出版商合作，确保所有注册电子文档按照时间表进行高效编辑和出版。   

• Ensure quality of regulatory submission documents that comply with appropriate conventions and meet correct format requirements per relevant ICH and other guidance at all stages of development. 确保注册申报文件的质量，使其符合相关技术规范，并满足研发各阶段适用的ICH指南及其它指导原则的格式要求。 

Education & qualifications 教育和任职资格:

Minimum Requirements – Education and Experience 最低要求-教育和工作经验: 

Manager level 经理级别: 

• Master's degree with major in Clinical Medicine, Pharmaceutical Science, Biology or relevant majors, with 3 years writing Regulatory or scientific submission/documents experience with pharma or CRO companies. 硕士学历，临床医学、药学、生物学等相关专业，并具有3年制药企业或CRO公司撰写注册文件的经验。 

OR 

• Bachelor’s degree with major in Clinical Medicine, Pharmaceutical Science, Biology or relevant majors, with 5 years of writing Regulatory or scientific submission/documents experience with pharma or CRO companies. 本科学历，临床医学、药学、生物学等相关专业，并具有5年制药企业或CRO公司撰写注册文件的经验。 

Sr. Manager level 高级经理级别: 

• Master's degree with major in Clinical Medicine, Pharmaceutical Science, Biology or relevant majors, with 5 years writing Regulatory or scientific submission/documents experience with pharma or CRO companies. 硕士学历，临床医学、药学、生物学等相关专业，并具有5年制药企业或CRO公司撰写注册文件的经验。

OR  

• Bachelor’s degree with major in Clinical Medicine, Pharmaceutical Science, Biology or relevant majors, with 7 years of writing Regulatory or scientific submission/documents experience with pharma or CRO companies. 本科学历，临床医学、药学、生物学等相关专业，并具有7年制药企业或CRO公司撰写注册文件的经验。

Other qualifications 其他任职资格: 

• Expertise in interpretation of guidance documents and be able to work independently using materials from previous interactions with healthcare authorities, literature, and clinical documentation (protocols, IB, treatment guidelines) to ensure development of timely, accurate and compliant, responses.熟练解读监管指南文件，能准确理解和运用相关注册资料、文献和临床文件（方案、研究者手册、治疗指南）、临床/非临床数据，确保及时、准确和合规的准备监管部门回复文件。

• Experience in working with collaborative, cross-functional teams with strong sense of team-work, regulatory writing experience for nonclinical, clinical, CMC or pharmacovigilance/safety information.具有跨职能团队协作的经验，强烈的团队合作精神，有关于非临床、临床、CMC及药物警戒/安全注册文件写作经验。

• Working knowledge of statistical concepts and techniques.具备统计概念和技巧的实用知识。

• Excellent written and oral communication skills.优秀的书面和口头沟通能力。

• Language: good reading/writing/oral English skills.英语阅读、写作和口语能力良好。

• Documented expertise in summarizing scientific content. 具备书面记录总结科学内容的能力。

• Demonstrated attention to details and ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy (Chinese and English).有高度的细节关注度，能够发现并纠正拼写、标点、语法（中文和英文）方面的错误，确保文件间/内的一致性、清晰度和准确性。 

• Ability to summarize regulatory guidelines and apply them appropriately and understand and interpret clinical/non-clinical data from different sources.能够总结和运用法规，理解和解释临床/非临床数据。

• Cross cultural sensitivity demonstrating understanding and acceptance of different cultural parameters. 具备跨文化敏感性，能够理解和接受不同的文化。 

About Angitia:

Established in June 2018, Angitia Biopharmaceuticals is a multinational research and development enterprise focusing on discovery and development of new drugs for grievous bone, muscle and joint diseases. The founder and the core team members of Angitia are seasoned scientific leaders in new drug discovery, development and management from both overseas and domestic large multinational companies. The company has built an organization distinguished by world-class scientists with talents that proficient in the pathophysiology of musculoskeletal diseases. We utilize cutting-edge technologies of genetics and molecular biology to uncover new mechanisms, signal transduction pathways and their interactions combined with computer aided drug design to identify new drug targets, and to discover and develop new biological and small molecule medicines. The company is committed to serving patients in need by carrying out innovative science includes internal research and external collaborations with academics and global biopharmaceutical companies. We are seeking people who are competent, ambitious and great team players to join our vibrant group.

Our mission is to discover, develop and commercialize breakthrough therapeutics that address the key unmet medical needs of serious musculoskeletal diseases.