l Develop and implement both strategies and plan to obtain regulatory approvals at research, development, and commercial levels for the responsible projects
l Plan and manage the preparation of regulatory filings as planned for the Manufacturing and Product licenses for submission to NMPA
l Maintain a library of Regulatory Affairs guidance and regulations to keep abreast of current regulatory guidance for domestic and international agency requirements for the responsible projects
l Follow up and updates all new regulations and laws issued concerning registration process for US FDA, EMA, NMPA and PMDA
l Master degree major in Medicine, Pharmacy, Pharmacology, Nursing, Natural Science or relevant qualification.
l Have experience for the regulatory submission as pre-IND, IND, MAA, BLA or variations.
l Business English is commanded.