Banner Image
  • Location

    Netherlands

  • Job title:

    RA Specialist

  • Sector:

  • Job ref:

    44684

  • Start Date:

    2020-08-06

The company:
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.

Job description:
The RA Specialist will ensures compliance with regulatory agency regulations and interpretations and will manage the Chemistry, Manufacturing and Controls (CMC) data verification.

Responsibilities:
  • 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
Requirements:
  • 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
Contact Us

SIRE LIFE SCIENCES B.V.

Staten Bolwerk 1
2011 MK Haarlem
The Netherlands
+31 (0) 20 658 9800

SIRE STAFFING SOLUTIONS B.V.

Keizersgracht 440A
1016 GD Amsterdam
+31 (0) 20 658 9804

SIRE LIFE SCIENCES DEUTSCHLAND GmbH

Theatinerstraße 11
80333 München
+49 (0) 89 3803 8966

SINCERE. INTELLIGENT. RESULT-DRIVEN. EXCELLENCE.