Our client is one of the global leader in healthcare and pharmaceutical products, with base in Leiden.The company focuses on the discovery, development, manufacture, and marketing of vaccines to protect people worldwide from infectious diseases.
The RA Specialist will ensures compliance with regulatory agency regulations and interpretations and will manage the Chemistry, Manufacturing and Controls (CMC) data verification.
- 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
- MSc in Pharmacy or a relevant field
- Experience in dossier development of Module 3 IND/IMPD or MAA/BLA
- CMC knowledge
- Hands on dossier development experience
- Good communication skills