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.
Hybrid in Kyiv, Ukraine
Your role will include:
- Liaising with clinical project teams to procure documents required for regulatory & ethics committee submissions
- Preparation of regulatory and ethics committee submission dossiers
- Review of translations of essential documents subject to clinical trial submissions
- Tracking regulatory project documentation flow and progress reporting
- Tracking changes/amendments to legislation requirements related to clinical research
- Maintaining the database of regulatory requirements
- Communication point for ethics committees and regulatory authorities
- Ensuring accurate and timely reporting to ethics committees and regulatory authorities
- Communication line for clinical project teams and PSI support services on regulatory matters
- Delivering regulatory-related training, as required