For this Innovative Leading Biopharmaceutical client in Leiden, I am urgently looking for a Regulatory Affairs professional who has experience with IND'S and the US market!
- You ensure compliance with regulatory agency regulations and interpretations
- Prepare responses to regulatory agencies' questions and other correspondence.
- Organize and maintain reporting schedules for new drug application and investigational new drug applications.
- Assist with preparing necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
- Provides solution to a variety of problems of moderate scope of complexity.
- Conduct searches of existing files for requested information
- Maintain and archive all regulatory documentation.
Send me your CV + Motivation to: firstname.lastname@example.org and i will give you a call ASAP!