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 of regulatory requirements