国际注册资深专员

工作职责:

主要职责 Major Duties and Responsibilities

1. 按照公司海外项目注册策略与药监部门的要求，进行申报资料的撰写、翻译和提交，保证申报资料的准确性与可靠性；Be responsible for writing, translation and submission of the application documentations in accordance with international registration strategy and the requirement of regulatory agency.Guarantee the accuracy and reliability of the application documentations.

2. 按照程序及时申报，并配合药品监管部门或 CRO 公司办理相关手续，保证申报工作按时完成. Submit the applications according to the procedures. Cooperate with the regulatory agencies or CRO companies to handle relevant procedures. Guarantee to complete the applications in timely manner.

3.与外部合作单位沟通协调，确保项目按期开展；Communicate and coordinate with external cooperation companies, to ensure that the project is carried out on schedule;

3.协调和跟进国际项目中和产品注册相关的工作，保证项目按期开展；Coordinate and follow-up on related work of registration in the international projects. Ensure the projects are carried out on schedule;

4. 负责联络、跟进国际临床试验各参与方，保证沟通交流准确、顺畅，并按期整理项目进展，保证项目按期开展；Communicate with the partners or subcontractors in international clinical trials, to provide active communication and summarize the project progress regularly. Ensure the projects are carried out on schedule;

5. 遵守公司规章制度，按照公司要求完成部门工作，并完成上级和公司交办的其他内容工作。Comply with the internal rules and regulations. Be able to finish work in accordance with company requirements, and

be able to complete other work assigned by superiors and company.

任职资格:

1. 硕士学历，医学、药学、生物学、化学等相关专业，有海外留学背景优先。Master degree and major background in medicine, pharmacy, biology, chemistry, etc. Experience of study abroad is preferred.

2. 具有疫苗研发，或注册申报、临床试验开展相关工作经验三年。Three years’ work experience in vaccine development, registration or clinical trials

3. CET-6 and above

4. 能独立查阅有关英文文献资料，撰写和审核各类英文材料与报告；Be able to access relevant literature references in English, draft and review reports and files in English independently;

5. 具有良好的沟通交流能力，清晰的口头和书面表达能力，善于进行积极活跃的沟通；With good communication skills, clear verbal and written expression and be good at active communication;

6. 具有独立工作的能力，并同时具有较强集体意识和良好的团队合作精神；Be able to work independently, with strong collective awareness and good team spirit;

7.了解疫苗生产过程，熟悉疫苗 GMP 法规。Acknowledge of vaccine production process and vaccine GMP regulations.