Vacature Regulatory Affairs Officer (Project based)

For our client in Noord-Holland we are looking for a Regulatory Affairs Officer. The position is project based for a duration of 6-8 Month.Our client is a dynamic pharmaceutical company with own product. The main responsibility of the Regulatory Affairs Officer will be to support Project management in the execution of activities necessary for the building of a registration dossier of a new biopharmaceutical product. Registration dossiers are established in collaboration with numerous internal and external parties. The work environment is very international with English as the predominant language.

Main Tasks:
" Ensuring timely delivery of final documents to be included in the registration dossier.
" Controlling and updating of the project timelines and milestones.
" Organizing document reviews in collaboration with internal and external writers and experts.
" Maintaining the document management system in collaboration with the external publisher.

A candidate for the position of Regulatory Affairs Officer should hold an academic degree (BSc/MSc), preferably in the field of medical, biomedical or pharmaceutical sciences. Excellent basic computer skills (Word, Excel, Outlook) are a must. Experience in project management and electronic document management is a plus. A candidate for this position should have 1-2 years relevant experience in the industry. Fluent use of the English language; both written and oral is a pre.

A nice project in a dynamic company. If you have any further question do not hesistate to contact Evelien Luijt on 071-8906000.

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