Our client is a professional Pharmaceutical organization, based in Noord-Holland Netherlands.
Leading and upcoming worldwide biopharmaeutical specicialised in strongly R&D based investigational solutions.
You are responsible for regulatory submissions in the Regulatory department, generally for commercial and new products.
You have the responsibility for preparing submissions, labeling and variations.
You assist with non-promotional and promotional copy review
You are responsible for maintaining various electronic regulatory systems
You are responsible for acquisition and development of required regulatory knowledge and skills.
You must have a understanding of regulatory requirements.
Project management of new submissions to ensure that dossiers are compiled and submitted in accordance with work plan commitments and internal KPIs
Coordination of project specific responsibilities. Create opportunities for learning and development.
Close interaction with other functions across R&D to gain early visibility of dossier content.
5+ years of Regulatory Affairs
GMP experience is an asset
Degree in a scientific field is preferred.
Excellent organization skills and ability to work on a number of projects with tight timelines is required.
Excellent English and Dutch both verball and written communication skills are required.
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