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Project Manager for Dossier harmonization (regulatory) activities

- Zaventem

Job content

Als Project Manager Dossier Harmonisation, you will provide project management support for 2 projects. 

Your main responsibilities will be:

Participation in Dossier Harmonisation Steering Committee and product-specific project team meetings (agenda preparation, writing of minutes, follow up of actions)

Planning, preparation, circulation, and revision of the Dossier Harmonisation Project Plan for designated projects/products (assembly of implementation plans, coordination of preparation and submission of dossier applications and responses to questions raised by Regulatory Authorities.)

Use of ETS-RT registration database to respond to queries and update records.  Actively work with the ETS-RT Administrators to correct identified issues.

Use of Global Document Management System (Veeva Vault) and ETS to store and retrieve marketing authorisation documentation and registration dossiers.

Use of the department communications systems to ensure visibility of current and planned submissions.

Participate in departmental activities as appropriate to meet project objectives.

Other specific duties and responsibilities as detailed by supervisor. 

  • Master of PhD in a scientific field
  • Experience in Project Management
  • Professional proficiency in English
  • Good communicator
  • Keen teamplayer

For more information: contact Aline Vandermeeren +32 16 30 95 09