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  • Locatie

    Zuid Holland, Netherlands

  • Functie titel:

    Regulatory Affairs Specialist

  • Sector:

    Biotechnology

  • Job ref:

    45755

  • Start datum:

    2021-03-01

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 be preparing responses to regulatory agencies' questions. Furthermore, he/she will gather and assemble information needed for submissions in accordance with regulations and relevant guidelines.

Responsibilities:
  • Preparing responses to regulatory agencies' questions
  • Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
  • Organize and maintain reporting schedules for new drug application and investigational new drug applications 
  • Conducting searches of existing files for requested information 
  • Maintaining and archiving all regulatory documentation 

Requirements:
  • BSc or MSc in Pharmacy or relevant field
  • 3-5 years of working experience in RA 
  • Experience in Dossier Development Module 2 and 3
  • Excellent writing and communication skills in English 
  • Hands-on experience in documentum based systems 

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
Neem contact op

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