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For a major player in the global pharmaceutical industry, we are looking for a CTA.
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 personal career coach, a purposeful networker and a mentor who sees to it that your expertise stays up-to date.
• Centralized Procedure products: local creation/review and approval of Educational Materials, SmPC, PIL, Labelling and artwork. • Mutual Recognition Procedure products: in collaboration with above-country operational hubs, prepare/review national Module 1 documents (SmPC, PIL, labelling, artworks) and ensure timely submission of Marketing Authorisation Applications and variations the FAMHP and the Luxemburg Ministry of Health; local creation/review and approval Educational Materials. • Clinical Trial Applications: in collaboration with above-country operational hubs, prepare CTA submission documentation for both initial application and subsequent amendments, and other maintenance activities for the life cycle of the CTA including response to Regulatory Authority queries. • Ensure timely communication of regulatory approvals and implementation dates to all stakeholders. • Populate and Maintain Regulatory Databases/ensure timely implementation and compliance. • Ensure full compliance to legal requirements and to internal Pfizer procedures.
• Bachelor or Master preferably pharmacy, biology, chemistry • Experience in Pharmaceutical Industry (Regulatory Affairs, Clinical Trials) is not a must but an advantage • Good interpersonal communication skills. • Fluent in English, Dutch and French (oral and written) • Well organised • Stress-resistant and a strong team player with the ability to work independently without supervision • 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