Regulatory Affairs Associate
hace 2 semanas
Who we are? Veterinary medicine manufacturers Vetpharma 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. In Vetpharma we are a highly qualified team. We have extensive experience in development, registration and marketing veterinary medicinal products, API's and nutraceuticals. Overview: Compiles 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. Active participation in product development. Responsabilities : To 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. Participate in the product development and regulatory strategy of the new products. Prepare, review and approve protocols and reports from CMOs or CROs. Compilation of required information for registration dossiers and variations according to European legislation. Registration submission and follow up with Health Authorities until product approval and launch. Coordination and preparation of Answers to deficiencies letters received from Health Authorities. Maintains regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies. Qualifications : Education: University Degree in life sciences (Veterinary, Pharmacy, Chemistry or Biology). Master is a plus. Languages: High level of English is a must; Knowledge of other European language is also a plus. Experience (years/area): minimum 2 years of experience required. Specific Knowledge: Very good knowledge of general pharmaceutical legislation and regulations and registration dossier format content. Proficiency with standard software tools (Word, Excel, PowerPoint, Project, etc.). Travels: Occasionally Personal skills: good communication skills, teamwork, results-oriented, autonomous, creative, and entrepreneurial Our benefits Flexible start time from Monday to Friday (full-time). Permanent contract.
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Quality and Regulatory Director
hace 2 semanas
Catalonia, España ARTO A tiempo completoPosition Overview The Director of Quality and Regulatory Affairs will play a central role in defining and executing the organization's overall quality and regulatory roadmap. This position oversees the Quality Control, Quality Assurance, and Regulatory Affairs functions, ensuring that operations, systems, and products consistently meet applicable GxP and...
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Quality and Regulatory Director
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Catalonia, España ARTO A tiempo completoPosition Overview The Director of Quality and Regulatory Affairs will play a central role in defining and executing the organization's overall quality and regulatory roadmap. This position oversees the Quality Control, Quality Assurance, and Regulatory Affairs functions, ensuring that operations, systems, and products consistently meet applicable GxP and...
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Quality and Regulatory Director
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Catalonia, España jobtraffic A tiempo completoPosition Overview The Director of Quality and Regulatory Affairs will play a central role in defining and executing the organization's overall quality and regulatory roadmap. This position oversees the Quality Control, Quality Assurance, and Regulatory Affairs functions, ensuring that operations, systems, and products consistently meet applicable GxP...
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Quality and Regulatory Director
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Catalonia, España jobtraffic A tiempo completoPosition OverviewThe Director of Quality and Regulatory Affairs will play a central role in defining and executing the organization's overall quality and regulatory roadmap. This position oversees the Quality Control, Quality Assurance, and Regulatory Affairs functions, ensuring that operations, systems, and products consistently meet applicable GxP and...
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Catalonia, España ARTO A tiempo completoPosition OverviewThe Director of Quality and Regulatory Affairs will play a central role in defining and executing the organization's overall quality and regulatory roadmap. This position oversees the Quality Control, Quality Assurance, and Regulatory Affairs functions, ensuring that operations, systems, and products consistently meet applicable GxP and...
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Trainee - Regulatory Affairs
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Catalonia, España WhatJobs A tiempo completoCONTRATO FORMATIVO PARA LA OBTENCIÓN DE LA PRÁCTICA PROFESIONAL REQUISITOS: HABER FINALIZADO ESTUDIOS EN LOS ÚLTIMOS 3 AÑOS NO HABER TENIDO UN CONTRATO DEL MISMO TIPO CON ANTERIORIDAD Who we are? Veterinary medicine manufacturers Vetpharma is the veterinary division of Chemo, part of the Insud Pharma group, providing Animal Health solutions. We are...
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