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For a major player in the global pharmaceutical industry, we are looking for a REGULATORY AFFAIRS ADMINISTRATOR.
Randstad’s mission is to shape the world of work by being a world leader in matching supply and demand in the labor market and in HR services. Randstad Professionals is part of the Randstad Group and creates opportunities for highly qualified and skilled professionals to work on successive projects on customers’ site. For you as specialist, Randstad Professionals wants to become a peronal career coach, a purposeful networker and a mentor who sees to it that your expertise stays up-to date.
A Regulatory Affairs Administrator ensures the appropriate licensing, marketing and legal compliance of the products. Combining knowledge of scientific, legal and business issues, they enable products to meet the required legislation. They advise on and coordinate the approval and registration the products.
• Artwork coordination and management : Initiate, prepare and follow-up artwork requests for Pfizer products in the Global Pfizer Artwork system, both for submission artwork as well for commercial artwork. Ensure artwork is in line with registered data and labels, is reviewed and corrected and implemented in time. Work together with the Artwork hub in UK and/or Manufacturing site Artwork Centers to coordinate and approve the artworks • Regulatory database management : Provide support in updating the local and global regulatory databases within the due timelines, and ensure accuracy and consistency of the data. Provide feedback to database system owners in case of issues and find/propose solutions for resolving and mitigation. • Provide support in the peer review of medicinal product labelling texts and artworks in order to ensure full accuracy and consistency, and compliance to local and EU guidance and requirements. Document the review in the appropriate global system. • Provide assistance and administrative support in the preparation, submission and follow-up of regulatory registration and variation dossiers for Belux medicinal products. Provide assistance and administrative support for the preparation, submission and follow-up of Certificates of Pharmaceutical Products (CPP) applications and ancillary documents for export countries • Notify and follow up out of stock situations to the authorities in Benelux. Liaise with other divisions to discuss the situation and find solutions. • Provide support and assistance in completing and remediating the local web-based local regulatory database ensuring population of historical data and/or verification of uploaded data and compliance • Back-up for administrative tasks in the team, including but not limited to payment of fees, standing orders, etc.
Background, experience • You have a Bachelor or Master preferably pharmacy, biology, chemistry • Good knowledge on manufacturing processes, dosage forms and analytical techniques is an advantage. • Experience in Pharmaceutical Industry (Regulatory Affairs CMC, pharmaceutical production plant) is not a must but an advantage • You have good interpersonal communication skills. • You are fluent in English, Dutch and French (oral and written)
Personal characteristics • You are well organised • You are stress-resistant and a strong team player with the ability to work independently without supervision. • You are accurate, thorough and you have eye for quality
wat bieden wij?
As an answer to your high level of education and flexibility, Randstad Professionals offers you a salary package on level, with extra-legal advantages: - Meal vouchers - Hospitalisation insurance - Group insurance - Representation cost - Development opportunities