法规专员

Job Responsibilities 工作职责：
1. Compile and prepare various documents related to product registration applications based on project or internal needs, including but not limited to the dossiers for communication/scientific advice (SA) meetings, supplementary applications, clinical trial applications (CTA/IND), marketing applications (BLA/NDA/MAA), annual reports, etc.
根据项目或公司内部需求，编撰与整合产品注册申请相关的各类文件，包括但不限于沟通交流/科学咨询（SA）会议资料包、补充申请、临床试验申请（CTA/IND）、上市申请（BLA/NDA/MAA）、年度汇报等；
2. Interface with drug regulatory authorities in different countries, such as NMPA/CDE, FDA, EMA, etc, in strong collaboration with other departments/ teams to ensure the efficient implementation of relevant work.
与各国药品监管部门（NMPA/CDE/FDA/EMA）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；
3. Actively involved and coordinate relevant activities in the submission process to ensure the application can be approved quickly and smoothly.
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；
4. Continue to learn and pay attention to the release and change of drug regulatory regulations in various countries. Sort out key changes, regularly publish relevant content and organize corresponding training.
持续学习和关注各国药品监管法规的发布和变更，梳理关键的变更内容，定期发布相关内容并组织相应培训；
5. Execute other duties as may be required by RA.
法规事务部门的其他日常工作。
Qualification 任职资格：
1. Experience and strong understanding of drug (especially biological products) research and development process.
对药品研发过程有较强的理解，并具备相关经验；
2. Excellent scientific writing and text editing skills are essential (Chinese and English). Critical attention to details. Proficient in using various office software.
出色的写作与文字编辑能力（中文与英文），且注重细节。能熟练运用各种办公软件；
3. Strong knowledge of the drug regulatory environments in various countries, familiar with relevant regulations such as FDA, EMA, NMPA and ICH guidelines. Possess the communication ability with drug regulatory authorities.
熟悉各国药品监管环境，了解FDA、EMA、NMPA和ICH等相关法规，并具备与药品监管部门的沟通能力;
4. Excellent literature and regulations retrieval capability.
出色的文献和法规的检索能力；
5. Excellent verbal and written communication skills in English and Mandarin.
优秀的英语与普通话的口头与书面沟通能力；
6. Strong individual contributor who also works with teams effectively, including a proven ability to work well under pressure.
较强的团队合作能力，包括良好的抗压能力；
7. May require travel to 5-10%.
能接受短期出差；
8. Bachelor degree or higher in a scientific discipline
理工科学士学位及以上；
9. At least 2 years of experience in the core activities of Regulatory/Technical Development.
拥有二年以上注册法规或药品研发关键环节的工作经验。