服务内容如下：
1. Responsible for module 1 documents preparation, such as certificate documents, INN, trade name, patent, etc. Responsible for dossier formatting.
2. Provides timely and high-quality regulatory submission support on nonclinical part.
3. Supports line manager to ensure timely submission delivery to HA for all life cycle activities, including IND, NDA, post-approval changes, renewal, annual report, etc.
4. Responsible for archiving, ensures that regulatory information management system is updated, and registration documents are archived timely.
5. Responsible for labelling (e.g. carton, inner label) and artwork execution.
6. Maintains the patent information and regularly monitors the patent statements of competitors on China patent register platform.
7. With support from line manager, continually monitors and collects the regulatory intelligence regarding submission regulations and assesses the potential impact to submission processes to ensure compliance and efficiency in the delivery of submissions.
8. Ensures regulatory submission activities compliant with company internal and local policies.
9. Supports other tasks assigned by line manager, such as ad-hoc tasks, contribute comments to Taskforce.
服务要求：
1. Bachelor or above degree in a Life Science related discipline
2. Good written and oral communication skills in English and Chinese
3. At least 1 year experience in the pharmaceutical industry, preferably in drug development or regulatory affairs.
4. Requires knowledge of applicable Regulatory Agency regulations, guidelines (eg, NMPA, CDE, ICH, FDA, EMA, etc).
5. Affinity to work with complex IT systems. Good knowledge with MS Office applications and Adobe Acrobat is required.
职能类别：生物工程/生物制药
关键字：ndaind