锦鲤求职岗位描述
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