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.
- 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.
- 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
- 1st of April
- Initially untill EOY
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 firstname.lastname@example.org