以上为北京时间。链接检查不代表仍在招聘，申请前请以招聘官网为准。
按这个岗位的城市和方向提醒，确认后才开启，可选择每日或每周。
负责大分子药物CMC申报文件的统筹、撰写与审核（涵盖IND、BLA等），为研发提供法规支持并跟进NMPA/FDA审评问题答复，参与现场核查及药物全生命周期合规管理。
The job role is responsible for CMC dossiers related planning,coordinating, management, reviewing and finalization, including but not limited to IND submission, CMC amendment and BLA fast approval.
DSUR CMC dossiers review and preparation.
Support the QC testing, registration and GMP inspection, MAH manufacture license.
Follow up and solve the CMC queries from Health Authority (NMPA, FDA, etc.).
Compliance support during the progress of Drug Development and Manufacture.
The project role will also contribute to regulatory process optimizations on relevant topics.
New Drug Development
Manage the CMC regulatory compliance of the whole life cycle, including risk assessment, change classification, deviation and OOT/OOS investigation.
Preparing and developing CMC strategies for process development, formulate specification items, stability schemes and comparability study, etc.
Coordinating all functions to develop filling plans, tracking timeline of CMC studies according to the plans.
Write and review CMC dossier, ensure the submission and timely response to HA, and obtain the approval from HA.
Product R&D Supporting
Support R&D team to conduct the studies according to related regulations and technical guidelines
Provide CMC regulatory advice to products development
When the project encounters problems, coordinate the meetings of cross-functions and put forward suggestions to meet the requirements of the regulation/guideline.
Support the drug registration QC testing
Be responsible for arranging on-site audit
Maintain up-to-date knowledge and expertise of relevant guidelines and regulations.
Provide impact analysis and formulate product registration strategies and plans
Other Assignments
科技推广和应用服务业
