Join our team of experts in regulatory 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 working arrangement in Prague, the Czech Republic
Your role:
- Prepare and oversee the preparation of clinical trial submission
- Acts as a Regulatory Lead in complex clinical trials and programs of clinical trials: coordination of CTIS submission, shared responsibility for developing global and country-level submission strategy
- Primary responsibility for discussing submission strategy with sponsors
- Identifying regulatory risks and working on mitigation plans
- Managing consistency of approaches and regulatory processes across multiple trials in programs of clinical trials
- Communicate with regulatory authorities, ethics committees, project teams and vendors on regulatory-related matters
- Review translations of essential documents subject to clinical trial submission
- Track the regulatory project documentation flow
- Review documents to greenlight IP release to sites
- Manage safety reporting to authorities
- Deliver regulatory training to project teams
- Assist with feasibility research and business development requests