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. 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 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. #J-18808-Ljbffr
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Senior Regulatory Affairs Specialist
hace 18 horas
Madrid, España Indero A tiempo completoThe Senior Regulatory Affairs Specialist will provide leadership for assigned projects regarding all regulatory activities that lead to startup of clinical trials and will oversee global/multinational complex large clinical trial submissions. This role will be responsible for sponsor-facing regulatory leadership and management of regulatory deliverables...
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Senior Regulatory Affairs Specialist
hace 18 horas
Madrid, España Indero A tiempo completoThe Senior Regulatory Affairs Specialist will provide leadership for assigned projects regarding all regulatory activities that lead to startup of clinical trials and will oversee global/multinational complex large clinical trial submissions. This role will be responsible for sponsor-facing regulatory leadership and management of regulatory deliverables...
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Regulatory Affairs Director
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Madrid, España MCR International A tiempo completo**CLM-2210-83** **REGULATORY AFFAIRS DIRECTOR** **MADRID** From MCR International, we are looking for a **Regulatory Affairs Director** for a well known Pharmaceutical company based in Madrid with the possibility of working remotely 50%. **Mission**: Define and implement the regulatory strategies to obtain marketing authorizations for the company's...
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Regulatory Affairs Associate
hace 3 semanas
Madrid, España Chemo A tiempo completoEn pocas palabrasPosición: Regulatory Affairs Associate - International MarketsLocalización: Azuqueca de HenaresExperiencia: al menos 4 años en funciones similares¿Quieres saber más?INSUD PHARMA opera en toda la cadena de valor farmacéutica, aportando conocimientos especializados y experiencia en investigación científica, desarrollo, fabricación,...
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Hybrid Regulatory Associate: E-Invoicing
hace 2 semanas
Madrid, España TRSS A tiempo completoA global leader in tax technology is seeking a Regulatory Associate to tackle complexities in e-invoicing compliance. This role offers the chance to contribute to the Regulatory Affairs team, impacting global operations. The ideal candidate has 1-3 years of experience in e-invoicing or tax technology and excels in communication and collaboration skills. This...
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Senior Regulatory Affairs Specialist
hace 2 semanas
Madrid, Madrid, España Indero A tiempo completoThe Senior Regulatory Affairs Specialist will provide leadership for assigned projects regarding all regulatory activities that lead to startup of clinical trials and will oversee global/multinational complex large clinical trial submissions.This role will be responsible for sponsor-facing regulatory leadership and management of regulatory deliverables...
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Regulatory Affairs Manager
hace 1 semana
Madrid, España Intelstack A tiempo completoJob Title: Contractor Local Regulatory Affairs ManagerLocation: SpainJob Type: Contract RoleDuration : 11 MonthsJob DescriptionWe are inviting applications for the role of Contractor Local Regulatory Affairs Manager for the Spain market. The ideal candidate will have extensive experience in regulatory affairs, specifically in lifecycle management (LCM) and...
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Regulatory Affairs Manager
hace 1 semana
Madrid, España Intelstack A tiempo completoJob Title: Contractor Local Regulatory Affairs ManagerLocation: SpainJob Type: Contract RoleDuration: 11 MonthsJob DescriptionWe are inviting applications for the role of Contractor Local Regulatory Affairs Manager for the Spain market. The ideal candidate will have extensive experience in regulatory affairs, specifically in lifecycle management (LCM) and...
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Regulatory Affairs Manager
hace 1 semana
Madrid, España Intelstack A tiempo completoJob Title: Contractor Local Regulatory Affairs ManagerLocation: SpainJob Type: Contract RoleDuration: 11 MonthsJob DescriptionWe are inviting applications for the role of Contractor Local Regulatory Affairs Manager for the Spain market. The ideal candidate will have extensive experience in regulatory affairs, specifically in lifecycle management (LCM) and...
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Técnico/a Regulatory Affairs
hace 21 horas
Madrid, España AC Marca A tiempo completo¡En AC Marca seguimos creciendo!Estamos buscando un/a Técnico/a Senior de Regulatory Affairs para que se una al equipo de nuestra planta en Sant Llorenç d'Hortons.Si tienes al menos 5 años de experiencia como Técnico/a de Regulatory, idealmente especializados en diferentes categorías de producto como biocidas y producto sanitario, inglés alto y...
