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.
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 applicationsCommunicate with regulatory authorities, ethics committees, project teams and vendors on regulatory-related mattersReview translations of essential documents subject to clinical trial submission.Track the regulatory project documentation flowReview documents to greenlight IP release to sitesManage safety reporting to authoritiesDeliver regulatory training to project teamsAssist with feasibility research and business development requests<...