Regulatory Affairs Trainee |
hace 3 semanas
Job Description Summary Regulatory Affairs Trainee About the role: Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us as a Founder of our 'new' Sandoz Commitment to Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. What are you going to do? Authorization processing management support (new MAs) Text preparation: translations and fractionation Management of national phases after EoP, including fractionation Preparation of national documentation for presentation (PoP, texts) Trade management, including databases and systems Fractionation management after variation submission Preparation of national documentation for submission (PoP, texts, e-application form...) eCTD submission Switch/transfer support: PLC and technical information Pruning & portfolio review support/execution General support for specific activities/projects Database maintenance and compliance - RegDB (including Art. 57), Excel spreadsheets Role Requirements: A career in pharmacy or ADE Master's Degree in Pharmaceutical Industry or Master's Degree in Registration of Industrial Medicines (CESIF, Official College of Pharmacists, IMF) English level C1 - C2 Open-minded person who can be a facilitator, stress tolerant, team player, able to prioritise, organised, attention to detail Office administration (Advanced Word, Excel) Desirable requirements: Nice to have previous experience Good knowledge of Portuguese Basic/Intermediate What's in it for you? Place of Work: Madrid (Hybrid Modality). Flexible Schedule: from Monday to Thursday from 8:00-9:30 to 17:30-19:00, on Fridays from 8:00-9:30 to 14:00-15:30. Internship Duration: 12 months. Competitive Retribution and Social Benefits. #J-18808-Ljbffr
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Regulatory Affairs Trainee
hace 5 meses
Madrid, España BD A tiempo completo**Job Description Summary**: As Regulatory Affairs Trainee you will develop yourself in supporting the activities of the EMEA (Europe, Middle East and Africa) Regulatory Affairs team. **-We are the makers of possible-**: BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no...
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Regulatory Affairs Trainee
hace 4 días
San Agustín de Guadalix, Madrid provincia, España BD A tiempo completo**Job Description Summary**: As Regulatory Affairs Trainee you will learn and develop from executing and supporting the activities of the Regulatory Affairs Operations team. The scope extends across BD business units and all EMEA countries. The activities are related with regulatory responsibilities to execute regulatory processes and provide support (with...
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Regulatory Affairs Trainee
hace 6 meses
Madrid, España BD A tiempo completo**Job Description Summary**: As Regulatory Affairs Trainee you will develop yourself in supporting the activities of the EMEA (Europe, Middle East and Africa) Regulatory Affairs team. The activities are related with the execution of regulatory processes of products related with Surgery, Urology and Critical Care, and Peripheral Intervention business units as...
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Trainee Quality
hace 1 mes
Madrid, España Ivf Hartmann Holding Ag A tiempo completoEn HARTMANN nos dedicamos a ayudar , cuidar , proteger y crecer . Apoyamos a los profesionales de la salud para que puedan centrarse en lo que realmente importa: impactar positivamente en la vida de las personas. Creamos soluciones que marcan la diferencia, y con tu compromiso podrás desarrollarte profesionalmente cada día. En HARTMANN tu contribución...
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Trainee Quality
hace 1 mes
Madrid, España Ivf Hartmann Holding Ag A tiempo completoEn HARTMANN nos dedicamos aayudar ,cuidar ,protegerycrecer.Apoyamos a los profesionales de la salud para que puedan centrarse en lo que realmente importa: impactar positivamente en la vida de las personas.Creamos soluciones que marcan la diferencia, y con tu compromiso podrás desarrollarte profesionalmente cada día.En HARTMANN tu contribución también...
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Regulatory Affairs Manager
hace 1 semana
Madrid, España Astrazeneca A tiempo completo.1. MISIÓNImplantar la estrategia regulatoria local definida por el Regulatory Affairs Head y coordinar/gestionar el plan de trabajo regulatorio local en estrecha colaboración con los equipos cross-funcionales locales y con la función global, asegurando el cumplimiento de los requerimientos internos y externos aplicables.2. RESPONSABILIDADESGestión y...
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Regulatory Affairs Expert
hace 4 semanas
Madrid, Madrid, España Sobi Group A tiempo completoKey Responsibilities and Accountabilities:Global Regulatory LeadershipThe Global Regulatory Affairs Lead provides global regulatory leadership of assigned programs, developing global regulatory strategies, including risk assessment and mitigation strategies. This role chairs a Global Regulatory Team (GRT) of regulatory Subject Matter Expert(s) and is the...
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Regulatory Affairs Professional
hace 1 semana
Madrid, Madrid, España Johnson And Johnson A tiempo completoRegulatory Affairs SpecialistJohnson and Johnson is seeking a skilled Regulatory Affairs Specialist to join our team in Madrid. This role offers a hybrid working model and is an exciting opportunity to contribute to our company's mission to build a world where complex diseases are prevented, treated, and cured.Key ResponsibilitiesSupport the growth of our...
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Regulatory Affairs Manager
hace 1 semana
Madrid, España Astrazeneca A tiempo completo.1. MISIÓN Implantar la estrategia regulatoria local definida por el Regulatory Affairs Head y coordinar/gestionar el plan de trabajo regulatorio local en estrecha colaboración con los equipos cross-funcionales locales y con la función global, asegurando el cumplimiento de los requerimientos internos y externos aplicables. 2. RESPONSABILIDADES Gestión y...
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Regulatory Affairs Specialist
hace 3 semanas
Madrid, Madrid, España Kenvue A tiempo completoRegulatory Affairs InternAt Kenvue, we are committed to delivering high-quality products that meet the highest standards of safety and efficacy. As a Regulatory Affairs Intern, you will play a critical role in ensuring compliance with regulatory requirements and maintaining our competitive edge in the market.Key Responsibilities:Regulatory Affairs:...
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Regulatory Affairs Manager
hace 3 semanas
Madrid, España AstraZeneca A tiempo completo**1. MISIÓN** Implantar la estrategia regulatoria local definida por el Regulatory Affairs Head y coordinar/gestionar el plan de trabajo regulatorio local en estrecha colaboración con los equipos cross-funcionales locales y con la función global, asegurando el cumplimiento de los requerimientos internos y externos aplicables. **2....
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Regulatory Affairs Manager
hace 7 días
Madrid, Madrid, España Oatly A tiempo completoOatly, the original oatmilk company, is expanding its presence in North America and seeks a highly skilled Regulatory Affairs Manager to join our team. As the leader of our US-based regulatory affairs function, you will provide expert guidance on food law and compliance matters.About the Role:This role involves leading the Oatly North America Regulatory...
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Regulatory Affairs Manager
hace 1 semana
Madrid, Madrid, España TRIUM Clinical Consulting NV A tiempo completoAbout the RoleWe are seeking a highly experienced Senior Regulatory Affairs Officer to join our team at QbD Group in Spain. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with pharmaceutical legislation and regulations.With a strong background in regulatory affairs, you will have expertise in ICH...
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Regulatory Affairs Expert
hace 1 mes
Madrid, Madrid, España Parexel A tiempo completoUnlock Your Potential in Regulatory AffairsWe are seeking a highly experienced Senior Regulatory Affairs Manager/Consultant to join our team at Parexel. As a key member of our regulatory affairs team, you will be responsible for managing client relationships, developing regulatory strategies, and ensuring compliance with EU guidelines.Key...
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Regulatory Affairs Specialist
hace 4 semanas
Madrid, Madrid, España Kenvue A tiempo completoWe are seeking a talented Regulatory Affairs Intern to join our team at Kenvue. As a Regulatory Affairs Intern, you will play a key role in ensuring the compliance of our products with regulatory requirements in Spain.Key Responsibilities:Coordinate and submit new drug applications, cosmetics, medical devices, food supplements, or similar products to...
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Regulatory Affairs Specialist
hace 1 mes
Madrid, Madrid, España Ventos A tiempo completoWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Ventós Group. As a key member of our international company, you will be responsible for maintaining our product database, collaborating in the homologation of new products and suppliers, and preparing technical documentation for our products.As a Regulatory Affairs Specialist,...
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Regulatory Affairs Specialist
hace 7 días
Madrid, Madrid, España Ventos A tiempo completoRegulatory Affairs Specialist Role:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Ventós Group in Sant Just Desvern, Barcelona. As a Regulatory Affairs Specialist, you will play a key role in maintaining our product database, collaborating with suppliers to homologate new products, preparing technical documentation, and...
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Madrid, Madrid, España Mcr International A tiempo completoQuality Assurance and Regulatory Affairs ManagerMADRIDQuality Assurance- Requirements:As a Quality Assurance and Regulatory Affairs Manager at Mcr International, you will participate in the implementation of a total quality culture in the company, ensuring full company compliance with MDR, ISO 13485, and 9001 requirements, and internal quality manuals,...
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Regulatory Affairs Specialist
hace 4 semanas
Madrid, Madrid, España Tbwa ChiatDay Inc A tiempo completoRegulatory Manager Job DescriptionWe are seeking a highly skilled Regulatory Manager to join our team at Precision for Medicine (CRO). The successful candidate will provide regulatory strategy and development guidance for optimal conduct of clinical trials, ensuring timely preparation of well-organized, quality regulatory submissions in compliance with...
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Regulatory Affairs Manager
hace 1 semana
Madrid, España Astrazeneca A tiempo completo1. MISIÓNImplantar la estrategia regulatoria local definida por el Regulatory Affairs Head y coordinar/gestionar el plan de trabajo regulatorio local en estrecha colaboración con los equipos cross-funcionales locales y con la función global, asegurando el cumplimiento de los requerimientos internos y externos aplicables.2. RESPONSABILIDADESGestión y...