Regulatory Affairs Associate
hace 1 semana
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. Main Responsibilities: 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.
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Regulatory Affairs Manager
hace 2 semanas
Catalonia, España G&L Scientific A tiempo completoThis role can be based in either our Barcelona , Belfast or London Office. We work on a hybrid basis. Ready to dive into some seriously meaningful science? We're looking for a seasoned CMC Regulatory Affairs pro who loves complex challenges, global coordination, and shaping regulatory strategy for a high-impact vaccine portfolio. You'll step in as our Senior...
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Regulatory Affairs Associate
hace 2 semanas
Catalonia, España Vetpharma A tiempo completoWho we are?Veterinary medicine manufacturersVetpharma 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...
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Regulatory Affairs Associate
hace 3 días
Catalonia, España Vetpharma A tiempo completoWho 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...
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Regulatory Affairs Associate
hace 3 días
Catalonia, España Vetpharma A tiempo completoWho we are?Veterinary medicine manufacturersVetpharma 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...
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Trainee - Regulatory Affairs
hace 1 día
Catalonia, España Vetpharma 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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Quality and Regulatory Director
hace 1 día
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...
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Trainee - Regulatory Affairs
hace 3 días
Catalonia, España Vetpharma A tiempo completoCONTRATO FORMATIVO PARA LA OBTENCIÓN DE LA PRÁCTICA PROFESIONALREQUISITOS:HABER FINALIZADO ESTUDIOS EN LOS ÚLTIMOS 3 AÑOSNO HABER TENIDO UN CONTRATO DEL MISMO TIPO CON ANTERIORIDADWho we are?Veterinary medicine manufacturersVetpharma is the veterinary division of Chemo, part of the Insud Pharma group, providing Animal Health solutions. We are located in...
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Technical Owner PV/RA
hace 1 semana
Catalonia, España Ubique Systems A tiempo completoExperience: 5+ years of experience in IT roles within the Life Sciences industry. At least 3 years in a Technical Owner, Application Manager, or Technical Lead role for Regulatory Affairs or Pharmacovigilance systems. Proven experience with one or more of the following systems: Regulatory Affairs: ArisGlobal LifeSphere RIMS, Veeva Vault RIM, Freyr RIMS,...
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Technical Owner PV/RA
hace 2 semanas
Catalonia, España Ubique Systems A tiempo completoExperience:5+ years of experience in IT roles within the Life Sciences industry.At least 3 years in a Technical Owner, Application Manager, or Technical Lead role for Regulatory Affairs or Pharmacovigilance systems.Proven experience with one or more of the following systems:Regulatory Affairs: ArisGlobal LifeSphere RIMS, Veeva Vault RIM, Freyr RIMS, Lorenz...
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Quality and Regulatory associate Junior
hace 3 días
Catalonia, España Mediktor A tiempo completoMediktor is looking for a QA/RA specialist! If you are passionate about applying the regulation to cutting edge technology and you would like to discover the Software Medical Device regulation, we are looking for you! The Team: As a member of the Quality Department, you will collaborate closely with all teams and departments at Mediktor, supporting them in...
