Locatie:
Provincie Zuid-Holland,Provincie Noord-Brabant,Provincie Noord-Holland /

Omschrijving:
Your new role
Your work as a Regulatory Affairs and Pharmacovigilance Officer will be focused on two primary focus areas: Regulatory Affairs and Artwork Development. Within Regulatory Affairs you will be responsible for the coordination, preparation and the filing of regulatory applications in line with the business objectives and timing - Representing the World Wide Regulatory Strategy in cross functional Project Teams, pertaining to new product development, approval, and launch, switch and business development opportunities

Besides that, you will assist in the development of innovative regulatory strategies to optimize regulatory approval timings, competitive positioning and global opportunities. You participate in the development and implementation of regulatory strategies for new and modified products and evaluate change controls for Regulatory impact which includes but is not limited to labelling. The Regulatory Affair and Pharmacovigilance Officer interpret government regulations and Industry Code of Conduct. Your responsibilities are also focused on the supervising of the necessary maintenance activities for products in the therapeutic area, e ensuring compliance with Global Procedures such as Medical Inquiries, Product Quality Complaints and Adverse event reporting.

Within the Artwork Development you will be responsible for drafting new and revised Label Text for Medical Product, Medical Devices, Dietary Supplements and Cosmetics and ensuring label text content, patient information leaflet/insert, master label, ingredient list, and other applicable documents, and is compliant with the EU and local regulation

What you'll need to succeed
To succeed in your role as a Regulatory Affairs and Pharmacovigilance Officer, you’ll need a bachelor degree, preferably science based. It is required to have at least a 2 year experience in the pharmaceutical industry and a regulatory experience in filing new applications. You speak English and Dutch fluently, both oral and written.

What you'll get in return
A Regulatory Affairs and Pharmacovigilance Officer position in a great atmosphere.

Your new company
Multinational pharmaceutical company in the regions Noord-Holland, Zuid-Holland and Noord-Brabant.

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.

Interesse?
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