RA Specialist

Location Leiden
Discipline: Biotechnology, Pharmaceutical
Job type: Temporary/Freelance
Contact name: Merel van Os

Contact email: m.vanos@panda-int.com
Job ref: 11849
Published: about 2 months ago

For this Innovative Leading Biopharmaceutical client in Leiden, I am urgently looking for a Regulatory Affairs CMC professional who has experience in dossier development of Module 3 IND/IMPD or MAA/BLA. The contract is initially until EOY.

RESPONSIBILITIES

  • Ensures compliance with regulatory agency regulations and interpretations.
  • Prepares responses to regulatory agencies' questions and other correspondence.
  • Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
  • Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
  • Provides solutions to a variety of problems of moderate scope and complexity.
  • Organizes and maintains reporting schedules for new drug application and investigational new drug applications.

PROFILE

  • Experience in dossier development of Module 3 IND/IMPD or MAA/BLA
  • Generally Requires 4-6 Years Work Experience
  • Able to work in a Documentum System
  • Skilled in Word
  • Hands on dossier development experience
  • RA CMC guideline knowledge
  • Good communication Skills

START DATE

  • 1st of April

DURATION

  • Initially untill EOY

INTERESTED?

If you’re interested in the above description, please apply with your CV and a letter of motivation by clicking on the ‘apply’ button below. For further information, please contact Merel van Os at +31 (0)20 20 44 502 or by email at m.vanos@panda-int.com