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.
Your role:
- Prepare clinical trial submission dossiers for Regulatory and Ethics Authorities, with a specific focus on Canadian and US regulatory submissions, including Import and Export license applications
- 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