We are looking for a Freelance Regulatory Affairs Officer for one of our pharmaceutical clients in the Antwerp region for a period of 1 year. Your responsibilities will involve making submission of regulatory nature, following up on these and making sure they are updated in the client’s systems.
Make regulatory submissions.
Provide product information.
Make sure review is done on artwork.
Follow up on regulatory submissions, update client’s system and archive.
Working with stakeholders on all levels.
PROFILE OF THE VALIDATION ENGINEER
Working knowledge with regulatory agencies in the Benelux. Knowledge of German and Austrian agencies is a plus.
Experience with European MAAs.
Experience with both local and European regulatory maintenance.
Knowledge of both local and European labelling and/or artwork.
Organizational skills to handle high priority projects.
Able to work with all aspects of Microsoft Office and databases.
Good in presentations.
Good written and verbal skills in English, Dutch, and German.
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