Regulatory Affairs Manager
hace 4 días
Job Title: Contractor Local Regulatory Affairs ManagerLocation: SpainJob Type: Contract Role Duration: 11 MonthsJob DescriptionWe are inviting applications for the role of Contractor Local Regulatory Affairs Manager for the Turkey market. The ideal candidate will have extensive experience in regulatory affairs, specifically in lifecycle management (LCM) and line extensions for cardiovascular products. A strong understanding of ICH guidelines and local regulatory requirements in Turkey is essential.ResponsibilitiesDocument Management: Author and review documents related to post-approval changes and line extensions, ensuring compliance with regulatory standards.Change Handling: Manage post-approval changes by assigning appropriate categories based on regulatory guidelines, ensuring all changes are documented and compliant.Issue Resolution: Escalate, notify, and resolve any issues that may impact final submissions to regulatory authorities.Lifecycle Management: Take end-to-end responsibility for the lifecycle management of products registered in the Turkish market, ensuring all regulatory requirements are met throughout the product's life.Internal Tracking: Maintain an internal tracker for post-approval changes and line extension submissions, ensuring timely updates as per anniversary requirements.Regulatory Strategy Development: Design regulatory strategies and make decisions regarding Chemistry, Manufacturing, and Controls (CMC) filings to support product registration and compliance.Qualifications We SeekMinimum Qualifications / SkillsBachelor's Degree in Pharmacy (B. Pharmacy) or Master's Degree in Pharmacy (M. Pharmacy).Preferred Qualifications / SkillsEnsure adherence to specific project specifications or standards throughout the submission lifecycle.Demonstrate effective time management and organizational skills to manage multiple time-sensitive assignments.Understand the business value of quality and compliance, adjusting behaviors to drive high-quality deliverables.Solve problems independently, utilizing existing solutions from a new perspective.Communicate complex issues effectively both verbally and in writing to build alignment among stakeholders.Adapt to changing environments while staying current with new processes and procedures.Depending on experience level, mentor newly hired staff or lead a team of junior staff.Flexibility in responding to changing priorities or unexpected events while balancing multiple tasks to achieve business goals.Need to know Spanish language and Spain regulations
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Regulatory Affairs Manager
hace 3 días
Vitoria-Gasteiz, España Intelstack A tiempo completoJob Title: Contractor Local Regulatory Affairs Manager Location: Spain Job Type: Contract Role Duration : 11 Months Job Description We are inviting applications for the role of Contractor Local Regulatory Affairs Manager for the Turkey market. The ideal candidate will have extensive experience in regulatory affairs, specifically in lifecycle management (LCM)...
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Regulatory Affairs Manager
hace 3 días
Vitoria-Gasteiz, 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 Turkey market. The ideal candidate will have extensive experience in regulatory affairs, specifically in lifecycle management (LCM) and...
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Chemical Regulatory Affairs
hace 4 días
Vitoria-Gasteiz, España AdQualis Human Results A tiempo completoWe are seeking an experienced Chemical Regulatory Affairs to ensure that chemical and polymer products — both raw materials and finished goods — comply with global regulations and sustainability standards throughout their lifecycle. This EU-based position is critical for maintaining market access, minimizing compliance risks, and supporting innovation...
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Chemical Regulatory Affairs
hace 3 días
Vitoria-Gasteiz, España AdQualis Human Results A tiempo completoWe are seeking an experienced 💥Chemical Regulatory Affairs to ensure that chemical and polymer products — both raw materials and finished goods — comply with global regulations and sustainability standards throughout their lifecycle.This EU-based position is critical for maintaining market access, minimizing compliance risks, and supporting innovation...
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Técnico/A Regulatory Affairs
hace 6 días
Gasteiz / Vitoria, España Timup A tiempo completoEmpresa líder en el desarrollo y fabricación de productos de gran consumo con fuerte presencia internacional y un marcado enfoque en innovación, busca incorporar varios/as Técnicos/as de Regulatory Affairs especializados en diferentes categorías de producto: biocidas , y producto sanitario . Usted podría ser el solicitante perfecto para este trabajo....
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Senior Manager, Regulatory Labelling
hace 1 semana
Gasteiz / Vitoria, España Cpl Life Sciences A tiempo completoJob Title: Senior Manager, Regulatory LabellingLocation: Spain, -Fully RemoteSalary: Competitive Salary + Excellent Benefits Employee Type: PermanentAs a Senior Manager, Regulatory Labelling you will take leadership on everything related to Regulatory Labelling.Por favor, asegúrese de leer completamente el resumen y los requisitos de esta oportunidad de...
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TÉCNICO/A REGULATORY AFFAIRS
hace 4 días
Vitoria-Gasteiz, España RAS España A tiempo completo¿Eres un/a experto/a en asuntos regulatorios? ¡Ésta es tu oportunidad para unirte a una empresa líder en innovación y sostenibilidad en el sector químico! 🚀 Desde RAS Recruiting, especialistas en selección directa, te acompañamos en la búsqueda de tu nuevo proyecto profesional. Actualmente, buscamos TÉCNICOS/AS EN REGULATORY AFFAIRS para las...
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TÉCNICO/A REGULATORY AFFAIRS
hace 4 días
Vitoria, España RAS España A tiempo completo¿Eres un/a experto/a en asuntos regulatorios? ¡Ésta es tu oportunidad para unirte a una empresa líder en innovación y sostenibilidad en el sector químico! Desde RAS Recruiting, especialistas en selección directa, te acompañamos en la búsqueda de tu nuevo proyecto profesional. Actualmente, buscamos TÉCNICOS/AS EN REGULATORY AFFAIRS para las áreas...
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Quality And Regulatory Director
hace 4 días
Gasteiz / Vitoria, 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 and...
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Compliance Manager
hace 4 días
Gasteiz / Vitoria, España ARTO A tiempo completoPosition Overview¿Tiene las siguientes habilidades, experiencia e impulso para tener éxito en este puesto? Descúbralo a continuación.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...
