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  • Location

    Noord - Holland, Netherlands

  • Job title:

    Regulatory Affairs Specialist

  • Sector:

    Pharmaceutical

  • Job ref:

    45637

  • Start Date:

    2021-01-27

The Company 
Our client is a biotech and pharmaceutical organisation, based in Noord-Holland Netherlands. They focus on the development of medicines and vaccines. 

Role Description
You will be responsible for the submissions of the life cycle management and launches. Next to that you will implement the agency approvals.
 

Responsibilities
Ensure that all labels are complaint according to the Dutch law and legislations
- Prepare the finalization of documentation, NL Labeling, submission package
- Maintain the KPI's and ensure that the submissions are made on time
- Global database update (like SHARE, RWS-LOL, Veeva Vault, and cross references with SHARE)
- Provide support to the Regulatory Affairs Managers with their product portfolio


Requirements

- Min. Bachelor's degree in a Life Sciences subject
- Good knowledge of EU Regulatory Affairs and Dutch law and legislations

- Excellent scientific writing and presentation skills
- Familiar with end to end processes

Other information
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Windimi Post

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