Regulatory Toxicologist R&d
hace 9 meses
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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Project Toxicologist R&d
hace 9 meses
Vall de Bianya, España Zoetis A tiempo completoZoetis Veterinary Medicine Research and Development (VMRD) is looking for a skilled Toxicologist to join the Toxicology group in Global Pharmacokinetics, Dynamics, Metabolism & Safety (GPDMS) based in Kalamazoo, MI, or remotely in a challenging and dynamic position that provides technical leadership and expertise in Project toxicology. This position will...
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Principal Toxicologist
hace 1 mes
Sant Feliu de Llobregat, España Almirall A tiempo completo**Date**:5 Dec 2024 **Location**: SFEL - R&D SANT FELIU DE LLOBR, ES, ES - Spain **Company**:Almirall **Mission**: Identify a drug with an acceptable safety profile in humans that is appropriate for the intended population (e.g. therapeutic indication). How - Guide Drug Development on the safe progression of a drug up and through clinical testing and...
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Regulatory Affairs Specialist
hace 2 días
Azuqueca de Henares, España Chemo A tiempo completoAbout us: Insud Pharma is a recognised and respected company in the pharmaceutical and healthcare sector with more than 40 years of history and more than 7,000 employees in 50 countries specialising in the research, development, manufacture and marketing of active pharmaceutical ingredients and medicines for human and veterinary use. Chemo, industrial area...
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Regulatory Affairs Specialist
hace 1 día
Azuqueca de Henares, España Chemo A tiempo completoAbout us:Insud Pharma is a recognised and respected company in the pharmaceutical and healthcare sector with more than 40 years of history and more than 7,000 employees in 50 countries specialising in the research, development, manufacture and marketing of active pharmaceutical ingredients and medicines for human and veterinary use.Chemo, industrial area of...
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Regulatory Affairs Specialist
hace 1 semana
Azuqueca de Henares, España Chemo A tiempo completoAbout us:Insud Pharma is a recognised and respected company in the pharmaceutical and healthcare sector with more than 40 years of history and more than 7,000 employees in 50 countries specialising in the research, development, manufacture and marketing of active pharmaceutical ingredients and medicines for human and veterinary use.Chemo, industrial area of...
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Regulatory Affairs Specialist
hace 1 semana
Azuqueca de Henares, España Chemo A tiempo completoAbout us:Insud Pharma is a recognised and respected company in the pharmaceutical and healthcare sector with more than 40 years of history and more than 7,000 employees in 50 countries specialising in the research, development, manufacture and marketing of active pharmaceutical ingredients and medicines for human and veterinary use.Chemo, industrial area of...
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▷ Buen Salario: Regulatory Affairs Specialist
hace 3 días
Azuqueca de Henares, España Chemo A tiempo completoAbout us: Insud Pharma is a recognised and respected company in the pharmaceutical and healthcare sector with more than 40 years of history and more than 7,000 employees in 50 countries specialising in the research, development, manufacture and marketing of active pharmaceutical ingredients and medicines for human and veterinary use. Chemo, industrial area...
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Principal Toxicologist
hace 4 semanas
Sant Feliu de Llobregat, España Almirall Hermal GmbH A tiempo completoSelect how often (in days) to receive an alert:MissionLead the development and execution of non-clinical safety strategies throughout drug discovery, ensuring regulatory compliance and managing preclinical projects. Oversee toxicology studies, collaborate with cross-functional teams and external partners to integrate toxicology data into project goals, and...
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Principal Toxicologist
hace 4 semanas
Sant Feliu de Llobregat, España Almirall Hermal GmbH A tiempo completoSelect how often (in days) to receive an alert: Mission Lead the development and execution of non-clinical safety strategies throughout drug discovery, ensuring regulatory compliance and managing preclinical projects. Oversee toxicology studies, collaborate with cross-functional teams and external partners to integrate toxicology data into project goals, and...
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R&d&i Engineer
hace 7 meses
El Burgo de Ebro, España Saica Paper A tiempo completo**Description**: In the paper making process, the optimization of the chemicals that are added to the pulp is key in terms of cost reduction while keeping the quality of the paper. This position will be related to this optimization process in Saica Paper Mills. In the corrugated board manufacturing, the chemicals are introduced in the corrugator as first...
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(Ea-011) | Regulatory Affairs Associate
hace 2 días
Las Palmas de Gran Canaria, España Ares Consultores A tiempo completo.With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries.We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable...
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Manager, R/d
hace 7 meses
Talavera de la Reina, España Kensing A tiempo completo**APPLY**: **JOB TITLE**: Manager SNVE-Innovation & R/D** **DEPARTMENT**:Research & Development** **LOCATION: Talavera, Spain** **SUPERVISOR**:Sr. VP of Innovation & Technology*** **JOB SUMMARY** The role will be a valuable** **part of Kensing’s Technology and Innovation team and will play a key part in driving Kensing innovation and new business...
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IT Specialist with Regulatory Expertise
hace 3 semanas
La Almunia de Doña Godina, Zaragoza, España D-Ploy A tiempo completoCompany OverviewD-ploy is an IT and Engineering Solutions company with a global presence, serving clients in the EMEA region and the USA. We pride ourselves on delivering innovative and superior services and solutions to numerous industry-leading clients.SalaryThe estimated annual salary for this position is between $60,000-$80,000, depending on experience...
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Cornellà de Llobregat, España ZimVie Inc. A tiempo completoSelect how often (in days) to receive an alert:Regulatory Affairs Senior Specialist EMEA M/FJob Function: RegulatoryLocation: Cornella de Llobregat, B, ESWe are ZimVie, a publicly traded, global life sciences leader focused on restoring daily life to our patients by designing, manufacturing, and distributing a comprehensive portfolio of innovative tooth...
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Cornellà de Llobregat, España ZimVie Inc. A tiempo completoSelect how often (in days) to receive an alert: Regulatory Affairs Senior Specialist EMEA M/F Job Function: Regulatory Location: Cornella de Llobregat, B, ES We are ZimVie , a publicly traded, global life sciences leader focused on restoring daily life to our patients by designing, manufacturing, and distributing a comprehensive portfolio of innovative tooth...
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R&d Packaging Technologist
hace 7 meses
Jerez de la Frontera, España Cosmewax A tiempo completoIndefinido - Tiempo completo 11408, Jerez de la Frontera, Cadiz, EspañaLas principales funciones que la persona realizará son: - Desarrollo y homologación de packaging primario secundario y/o, terciario y personalizaciones del primario. - Coordinación de validaciones de homologaciones de packaging con Producción, Técnico y Regulatory. - Recopilación...
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R&D Packaging Technologist
hace 7 meses
Jerez de la Frontera, España Cosmewax A tiempo completoIndefinido- Tiempo completo 11408, Jerez de la Frontera, Cadiz, EspañaLas principales funciones que la persona realizará son:- Desarrollo y homologación de packaging primario secundario y/o, terciario y personalizaciones del primario.- Coordinación de validaciones de homologaciones de packaging con Producción, Técnico y Regulatory.- Recopilación y...
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Regulatory Affairs Senior Specialist EMEA M/F
hace 4 semanas
Cornellà de Llobregat, España ZimVie A tiempo completoWe are ZimVie , a publicly traded, global life sciences leader focused on restoring daily life to our patients by designing, manufacturing, and distributing a comprehensive portfolio of innovative tooth replacement and spine surgery solutions. Our company is founded on a legacy of trusted brands, products, and clinical evidence made possible through an...
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Regulatory Affairs Senior Specialist EMEA M/F
hace 4 semanas
Cornellà de Llobregat, España ZimVie A tiempo completoWe are ZimVie, a publicly traded, global life sciences leader focused on restoring daily life to our patients by designing, manufacturing, and distributing a comprehensive portfolio of innovative tooth replacement and spine surgery solutions. Our company is founded on a legacy of trusted brands, products, and clinical evidence made possible through an...
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Pharmaceutical Development Team Leader
hace 23 horas
Alcalá de Henares, España Chemo A tiempo completo.About the jobPosition: Pharmaceutical Development Team Leader - Solid Pharmaceutical FormsLocation: Azuqueca de Henares.Experience: at least 5 years in similar functions.Do you want to know more?INSUD PHARMA operates throughout the pharmaceutical value chain, providing expertise and experience in scientific research, development, manufacturing, sales and...