武汉招聘

工作职责：

Job Responsibilities:

1. Write regulatory documents according to internal and external needs.
2. 根据公司内、外部需求，撰写相应的法规文件。
3. Compile and prepare various registration application documents for drugs, including but not limited to communication meetings, clinical trial applications (CTA), marketing applications (BLA/NDA), annual reports, etc.
4. 编撰与整合各类药品相关的注册申请文件，包括但不限于沟通交流会议、临床试验申请、上市申请、年度汇报等。
5. Interface with NMPA/CDE, FDA, EMA, in strong collaboration with other department/team to ensure the efficient implementation of relevant work.
6. 与各国药品监管部门进行接洽，并与相关团队紧密协作来确保相关工作的高效进行。
7. Actively involved and coordinate relevant activities in the submission process to ensure the application can be approved quickly and smoothly.
8. 在注册申请过程中，积极参与并协调相关活动，确保申请事项能快速顺利获得批准。
9. Manage contractors/consultants as needed.
10. 根据项目需求，管理相应的第三方实验室或顾问。
11. Assist in internal and cross-functional regulatory development policy.
12. 从法规角度，协助部门内部和其他部门制定研发策略。
13. Execute other duties as may be required by RA.
14. 法规事务部门的其他日常工作。

Job Requirements:

1. Bachelor degree or higher in a scientific discipline
2. 理工科学士学位及以上。
3. 2-3 years of experience in the core activities of Regulatory/Technical Development
4. 拥有二至三年法规或药品研发关键环节的经验。
5. Experience and strong understanding of drug research and development
6. 对药品研发过程有较强的理解，并具备相关经验。
7. Scientific writing and editing skills are essential (Chinese and English)
8. 系统的写作与编辑能力（中文与英文）
9. Critical attention to details
10. 注重细节
11. Strong knowledge of the regulatory environment, FDA/EMA/NMPA regulations, ICH guidelines, and have the communication ability with drug regulatory authorities
12. 熟悉各国药品监管环境，了解FDA、EMA、CFDA和ICH等相关法规，并具备与药品监管部门的沟通能力。
13. Excellent verbal and written communication skills in English and Mandarin
14. 优秀的英语与普通话的口头与书面沟通能力。
15. Strong individual contributor who also works with teams effectively, including a proven ability to work well under pressure
16. 较强的团队合作能力，包括良好的抗压能力。
17. May require travel to 5-10％
18. 能接受短期出差。

鼎康生物是一家领先的CDMO公司，可提供一站式的CMC解决方案，支持从早期药物开发到后期临床研究和商业化cGMP生产。鼎康引进了全球***模块化生物制药工厂Kubio；为客户开发的多个产品已经在全球20多个国家进行临床试验。在不久的将来，鼎康生物总产能将超过140,000L。我们承诺通过技术和生产创新，使全球患者都能负担得起具有国际标准的生物药物，提高治疗水平以改善人类健康。