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Trainee - regulatory affairs

Barcelona
Vetpharma
Publicada el 9 enero
Descripción

PCONTRATO FORMATIVO PARA LA OBTENCIÓN DE LA PRÁCTICA PROFESIONAL /ppREQUISITOS: /pulliHABER FINALIZADO ESTUDIOS EN LOS ÚLTIMOS 3 AÑOS /liliNO HABER TENIDO UN CONTRATO DEL MISMO TIPO CON ANTERIORIDAD /li /ulpbr/ppWho we are? /ppbr/ppbVeterinary medicine manufacturers /b /ppbr/ppVetpharma is the veterinary division of Chemo, part of the Insud Pharma group, providing Animal Health solutions. We are located in Barcelona, where the group was founded in 1977. /ppIn Vetpharma we are a highly qualified team. /ppbr/ppWe have extensive experience in development, registration and marketing veterinary medicinal products, API’s and nutraceuticals. /ppbr/ppbOverview: /b /ppbr/ppCompiles and manages the Registration dossier or the Variation packages and coordinates the submission and follow up until product approval and launch or change implementation. Organizes regulatory information, logs and tracking. /ppActive participation in product development. /ppbr/ppbResponsabilities /b: /ppbr/pulliTo stay updated on changes in legislation and regulations and advises and gives interpretation on the potential impact to the product registration, marketing, manufacturing or development. /liliParticipate in the product development and regulatory strategy of the new products. /liliPrepare, review and approve protocols and reports from CMOs or CROs. /liliCompilation of required information for registration dossiers and variations according to European legislation. /liliRegistration submission and follow up with Health Authorities until product approval and launch. /liliCoordination and preparation of Answers to deficiencies letters received from Health Authorities. /liliMaintains regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies. /li /ulpbr/ppbQualifications /b: /ppbr/pullibEducation: /b University Degree in life sciences (Veterinary, Pharmacy, Chemistry or Biology). Master is a plus. /lilibLanguages: /b High level of English is a must; Knowledge of other European language is also a plus. /lilibExperience (years/area): /bNo experience is required. /lilibSpecific Knowledge: /bVery good knowledge of general pharmaceutical legislation and regulations and registration dossier format content. Proficiency with standard software tools (Word, Excel, PowerPoint, Project, etc.). /lilibTravels: /b Occasionally /lilibPersonal skills: /b good communication skills, teamwork, results-oriented, autonomous, creative, and entrepreneurial /li /ulpbr/ppbOur benefits! /b /ppbr/pulli⏰ Flexible start time from Monday to Friday (full-time). /lili /ul /li

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