XDES projects bemiddelt in technische functies voor de industriële sectoren: Pharma, Chemie, Petrochemie, Energie en Levensmiddelen.Job DescriptionPrimary Objective of this position is to act as a point of entry in the Global RA organization for the RA representatives in the designated countries. Arrange documents, data, samples, test materials and all other items necessary for obtaining and maintaining marketing authorizations. Ensure timely availability of the requested materials, in line with the licensing strategy. Act as intermediate between GRA Product Managers and RA representatives in the designated countries. Support fulfillment of any regulatory commitment given during a registration procedure. To send out variation packages, if necessary, to the country operations and ensure timely follow up. To communicate new, amended and renewal marketing authorizations to all relevant people and departments plus to enter and check these data in(to) the GRA information systems. When receiving questions from the various authorities through the local companies, compiling answers, where necessary with support of colleagues within the GRA department or from other disciplines. To participate in multi-discipline projects. To signal and communicate internally, trends in registration requirements of the designated countries.Participate in determining registration strategies for the designated countries. Maintain good working relation with contacts. Act proactively based on planning information and licensing strategy in providing the CORA with the necessary documentation and materials. Act as an intermediate between R&D and CORA on specific country requirements. Participate in new product development teams as content expert on registration requirements for designated countries.Job RequirementsHBO Bachelor or equivalent experience in compliance or regulatory affairs environment within the animal health industry. Basic to thorough knowledge of the biological and pharmaceutical product portfolio. Fluent English and Dutch speaking, reading and writing. A service minded team player with a well-developed cultural awareness. Ability to cope with periods of stress and high workload. Ability to prioritize effectively. Accurate and efficient. Ability to gain in-depth understanding of internal processes. Sound knowledge of various licensing requirements in designated countries and on a global level. Full proficiency with information systems (e.g. Microsoft, Oracle). Excellent communication skills. Experienced in working with international contacts, able to be patient and open to other cultural habits: Knowledge about Chinese culture and professional behavior, as well as experience in collaboration with Chinese colleagues (on regulatory matters) is a true asset. Proactively provide ideas for improvement of current processes.Salary and BenefitsMarktconformContact UsVoor meer informatie neem je contact op met Joost Storms, bereikbaar op telefoonnummer 023 55 78 529 of via e-mail: – Klik op de solliciteer-button om te solliciteren – Kenmerk: 7178.