Job Description
Job Description
Join our team of experts in regulatory and ethics submissions of clinical studies. You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career.
Office-based in Shanghai/Beijing
Your role:
Liaises with project teams to procure documents necessary for regulatory and ethics committee submissions.Prepares regulatory and ethics committee submission dossiers, including applications for import and export licenses.Reviews translations of essential documents subject to regulatory or ethics committee submissions, if regionally applicable (shared with project teams).Tracks regulatory project documentation flow and progress reporting.Tracks changes/amendments to legislative acts pertaining to clinical trials in PSI countries and timely notifies all parties involved.Under supervision maintains a database ...