Regulatory Toxicologist R&d
hace 2 semanas
Toxicological Assessment support: Safety assessments for formulation excipients, degradant materials, ingredients, and residual solvents in drug substances and drug products
- Toxicological Assessment supporting manufacturing: Qualifying impurities in the manufacturing process for drug substances and drug products; safety assessments for extractable and leachable; cross-over contamination of products at shared facilities and cleaning limits.
- Perform rigorous toxicology gap analysis, data mining, and systematic literature review.
- Toxicological evaluation and establishment of a hazard and health
- based exposure limits such as Permitted Daily Exposure (PDE), Margin of exposure (MoE) etc.
- Health hazard/ Medical assessments: supporting pharmacovigilance, product quality, and out-of-specification batches.
- User/handler safety support: Safety support for project teams (writes the documents, assembles various scenario calculations and risk mitigation proposals, packaging choice, label language)
- Regulatory filing support: Integration of toxicology, human food safety, target animal safety, and user safety assessments into filing documents
- Response to global regulatory queries
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Senior Regulatory Specialist
Encontrado en: beBee jobs ES - hace 4 días
Hospitalet de Llobregat, Barcelona, España Ecolab A tiempo completoAdditional Job DescriptionAre you looking for a career in a multinational company? Ecolab is currently seeking a Senior Regulatory Specialist Biocides. This is an office-based role; the candidate may reside near one of our offices in:Vimercate (Italy)Barcelona (Spain)Northwich (UK)Monheim (Germany)Lille (France)Your ResponsibilitiesSet up the regulatory...
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Statistician R&d
hace 4 días
Sant Feliu de Llobregat, España Almirall A tiempo completo**Date**:14 Nov 2023 **Location**: SFEL - R&D SANT FELIU DE LLOBR, ES, ES - Spain **Company**:Almirall **Mission**: The Junior Statistician will be responsible of the design and statistics of clinical trials and clinical development projects within Almirall. The Junior Statistician will partner with senior scientists in clinical (Global Development and...
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Senior Regulatory Specialist
Encontrado en: beBee S ES - hace 4 días
L'Hospitalet de Llobregat, España Ecolab A tiempo completoAdditional Job Description Are you looking for a career in a multinational company? Ecolab is currently seeking a Senior Regulatory Specialist Biocides. This is an office-based role; the candidate may reside near one of our offices in: Vimercate (Italy) Barcelona (Spain) Northwich (UK) Monheim (Germany) Lille...
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Regulatory Affairs Specialist CMC
Encontrado en: beBee S ES - hace 3 semanas
SFEL - R&D SANT FELIU DE LLOBR, España Almirall A tiempo completoMission Provide regulatory advice and prepare and maintain the chemical-pharmaceutical regulatory documentation for strategic brands for international and local products, maximising compliance with current guidelines while minimising regulatory commitments. Tasks and Responsibilities Participate in different projects (Pharma and Chemistry) developed by the...
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Regulatory Affairs Specialist CMC
Encontrado en: beBee jobs ES - hace 7 días
SFEL - R&D SANT FELIU DE LLOBR, España Almirall A tiempo completoMissionProvide regulatory advice and prepare and maintain the chemical-pharmaceutical regulatory documentation for strategic brands for international and local products, maximising compliance with current guidelines while minimising regulatory commitments.Tasks and ResponsibilitiesParticipate in different projects (Pharma and Chemistry) developed by the...
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EMEA Regulatory Affairs Sr. Manager
Encontrado en: beBee S ES - hace 3 semanas
L'Hospitalet de Llobregat, España Vantage A tiempo completoVantage is a leading supplier of naturally derived specialty ingredients and formulations that cater to the evolving needs of industrial and consumer markets. Through our chemistries, our customer focus and our global footprint, we are ENABLING TOMORROW’S SOLUTIONS TODAY. As a company on the move, you’ll be working as part of a collaborative team...
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Development Project Lead
hace 2 días
Sant Feliu de Llobregat, España Almirall A tiempo completoFecha: 09-mar-2023- Ubicación: SFEL - R&D SANT FELIU DE LLOBR**Mission**: To steer the R&D project, leading efficiently and effectively the team, and ensuring the delivery of the maximum project value with the approval of the product and its life Cycle management. The Global R&D Project Leader (PL) is accountable for the development strategy and integrated...
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Development Project Director
hace 2 días
Sant Feliu de Llobregat, España Almirall A tiempo completoFecha: 09-mar-2023- Ubicación: SFEL - R&D SANT FELIU DE LLOBR**Mission**: To steer the R&D project, leading efficiently and effectively the team, and ensuring the delivery of the maximum project value with the approval of the product and its life Cycle management. The Global R&D Project Leader (PL) is accountable for the development strategy and integrated...
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Safety Physician Trainee
hace 2 días
Sant Feliu de Llobregat, España Almirall A tiempo completoFecha: 27 jul. 2023- Ubicación: SFEL - R&D SANT FELIU DE LLOBR**Misión**: Patient safety first, ensure Almirall medical solutions have an adequate benefit/risk profile ensuring benefits outweigth risks **Funciones y responsabilidades**: Support the patient safety team providing clinically meaningful input in pharmacovigilance activities which include but...
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Pharmacokinetics and Drug Metabolism Specialist 1
Encontrado en: beBee jobs ES - hace 1 semana
SFEL - R&D SANT FELIU DE LLOBR, España Almirall A tiempo completoMissionBe a member of R&D teams to provide an expert DMPK & Bioanalysis support to Large Molecule therapy projects. Implementation and validation of adequate bioanalytical strategies, with focus on PK assays, PD assays and immunogenicity assays, across the project lifecycle in a multidisciplinary environment. Coordinate sample analysis including...
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Intern / Becario/a Bioinformatics
Encontrado en: beBee jobs ES - hace 3 semanas
SFEL - R&D SANT FELIU DE LLOBR, España Almirall A tiempo completoMissionAlmirall is seeking a highly motivated scientist to work as an intern for the Computational Biology and Bioinformatics team section of the R+D Data Science Dpt. with interest in the application and development of computational tools to analyze omics data to accelerate a series of research discovery programs. The candidate may be involved in the...
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Pharmacokinetics and Drug Metabolism Specialist 1
Encontrado en: beBee S ES - hace 1 semana
SFEL - R&D SANT FELIU DE LLOBR, España Almirall A tiempo completoMission Be a member of R&D teams to provide an expert DMPK & Bioanalysis support to Large Molecule therapy projects. Implementation and validation of adequate bioanalytical strategies, with focus on PK assays, PD assays and immunogenicity assays, across the project lifecycle in a multidisciplinary environment. Coordinate sample analysis including...
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TEMP Regulatory Affairs Specialist EMEA
Encontrado en: Talent ES C2 - hace 1 semana
Cornellà de Llobregat, España ZimVie US Corp LLC A tiempo completoWe are ZimVie, a publicly traded, global life sciences leader focused on restoring daily life by advancing clinical technology to improve patients’ smiles, function, and confidence. Our company is founded on a legacy of trusted brands, products, and clinical evidence made possible through an inclusive and collaborative culture that empowers our team...
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Service Design Manager
hace 2 horas
El Prat de Llobregat, España G D Mobile Securities A tiempo completoEn un mundo que cambia rápidamente, se necesita un espíritu pionero para crear tecnología fiable. Hacemos posible la conectividad segura para miles de millones de personas en todo el mundo. En Giesecke+Devrient, desempeñará un papel clave en la realización de la transformación digital. Giesecke+Devrient is a global company that offers security...
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Intern / Becario/a Bioinformatics
Encontrado en: beBee S ES - hace 3 semanas
SFEL - R&D SANT FELIU DE LLOBR, España Almirall A tiempo completoMission Almirall is seeking a highly motivated scientist to work as an intern for the Computational Biology and Bioinformatics team section of the R+D Data Science Dpt. with interest in the application and development of computational tools to analyze omics data to accelerate a series of research discovery programs. The candidate may be involved in the...
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Tratamiento De Aguas (Goloso, El), España GSK A tiempo completo**Site Name**: GSK Tres Cantos, Madrid **Posted Date**: Feb 7 2024 **Therapeutic Area Director, Therapeutic Area Medical Affairs Lead (Vaccines)**: As a Director you will play a key role and will be a member of the GSK Pharma Research & Development Unit. The role reports directly into the VP Medical Director, Spain. **_ Job purpose:_** Responsible for...
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ADME & DMPK Senior Scientist
Encontrado en: beBee jobs ES - hace 1 semana
SFEL - R&D SANT FELIU DE LLOBR, España Almirall A tiempo completoMissionBe a member of R&D project teams to provide expert ADME&DMPK support across a project lifecycle in a multidisciplinary environment with special focus between the early stages of drug discovery through candidate nomination and early clinical development. Ensure that ADME profiling, PK/PD, M&S, human dose predictions or other related deliverables are...
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ADME & DMPK Senior Scientist
Encontrado en: beBee S ES - hace 6 días
SFEL - R&D SANT FELIU DE LLOBR, España Almirall A tiempo completoMission Be a member of R&D project teams to provide expert ADME&DMPK support across a project lifecycle in a multidisciplinary environment with special focus between the early stages of drug discovery through candidate nomination and early clinical development. Ensure that ADME profiling, PK/PD, M&S, human dose predictions or other related deliverables...
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ADME & DMPK Senior Scientist
Encontrado en: beBee jobs ES - hace 6 días
SFEL - R&D SANT FELIU DE LLOBR, España Almirall A tiempo completoMissionBe a member of R&D project teams to provide expert ADME&DMPK support across a project lifecycle in a multidisciplinary environment with special focus between the early stages of drug discovery through candidate nomination and early clinical development. Ensure that ADME profiling, PK/PD, M&S, human dose predictions or other related deliverables are...
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Patient Safety Senior Director
Encontrado en: beBee S ES - hace 3 semanas
SFEL - R&D SANT FELIU DE LLOBR, España Almirall A tiempo completoMission The director of patient safety at Almirall is accountable for: Establishing and maintain a Global/Corporate Pharmacovigilance system that protects patients and users of Almirall medical solutions. Acting as the EU Qualified Person for Pharmacovigilance (QPPV) and UK QPPV. Ensures an adequate safety profile of investigational medicinal products and...