Role DescriptionFor this company registrations are key to the business. In your role as Regulatory Affairs specialist, your main responsibility is to do registrations for various global markets . You will have a supportive role in creating awareness and exchange of knowledge about international regulations and changes. In addition, you interact with internal and external stakeholders and you will ensure that they are provided with the required information. Next to that, you are involved in the development of strategic plans which are related to the Regulatory Affairs and the implementation.
ResponsibilitiesOn a daily basis you are responsible for the collection and implementation of regulations in relation to the specification of various products. Furthermore, your tasks include: • Active role in maintenance and (new) product registrations for particular foreign markets • Supportive role for both internal and external stakeholders about RA related topics • Development and assessment of the documentation database • Development and adjustment of strategic plans and assessment of procedures for verification and validation projects • Supporting execution of evaluation and risk management procedures • Application and implementation of international legislation and documentation
Requirements• Master or Bachelor • Minimal 1 year of experience in the pharmaceutical/ biotechnology or medical devices sector • Minimal 1 year of experience in a RA role • Preferably knowledge of the international regulations such as Europe and US • Excellent writing and verbal skills in English and preferably business level understanding of Dutch • Preferably knowledge of GMP, GDP, ISO 13485, particularly the 2016 norm • Strong analytical skills and eye for detail • Team player, yet individual operator
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