Regulatory Affairs Specialist

Location Leiden, Netherlands
Discipline: Biotechnology
Contact name: Michelle Terraneo

Contact email: m.terraneo@panda-int.com
Job ref: 10586
Published: about 2 months ago

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!

Responsibilities:

  • 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.

INTERESTED?

Send me your CV + Motivation to: m.terraneo@panda-int.com and i will give you a call ASAP!