Regulatory Affairs in Clinical Trials

We are looking for a Regulatory Officer to join our team 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.

Only CVs in English will be accepted

Your role:

• Prepare clinical trial submission dossiers for Regulatory Authorities
• Prepare country level patient facing documents
• Communicate with regulatory authorities, 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