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  • Location

    Zuid-Holland, Netherlands

  • Job title:

    Senior Regulatory Affairs Specialist

  • Sector:

    Biotechnology, Pharmaceutical

  • Job ref:

    44748

  • Startdate:

    2020-09-01

The company
Our customer is one of the biggest producers of vaccines in the world. The company uses its extensive and innovative technology to combat life-threatening diseases such as Corona, HIV and Ebola. 

Role 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

Other information
Are you interested and want to apply for this role? Please fill out your application via the apply button below and contact Guilherme Tokunaga

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