Senior Regulatory Affairs Consultant
hace 7 días
When our values align, there's no limit to what we can achieve. About the Role We are seeking an experienced Regulatory Affairs professional to join our team as a European Labelling & Promotional Regulatory Specialist. This key position provides expert guidance across a Therapeutic business unit, delivering both strategic and operational regulatory input to cross-functional teams. The role can be home or office based in various European locations. Key Responsibilities EU Product Information Management: Create, update and maintain EU Product Information in line with CCDS, Agency RTQ, and current labelling requirements Serve as the key point of contact for EU Product Information for both internal and external stakeholders Lead reviews, round tables, and approvals for EU Product Information in appropriate systems according to SOPs Deliver competitive labelling searches and contribute to TLP for early development assets Operational Excellence: Ensure timely tracking and management of all EU Product Information in appropriate systems Lead Readability Testing processes including vendor selection, agreement management, questionnaire review, and submission of final reports Coordinate Linguistic Review processes with LR Coordinator according to SOPs Communicate proactively with the Artworks team for artwork and mock-up changes, participating in Change Control Processes Leadership & Collaboration: Lead the Local Labelling Committee for creation, review and approval of EU Product Information Serve on the EU Clearance Committee as primary regulatory reviewer for promotional materials Build strong relationships with EU and Global Regulatory teams, local business partners Monitor changes in EMA labelling requirements and keep the organization informed of technology requirements Qualifications & Skills required for the role: University degree in a life science discipline Strong knowledge of EU regulatory requirements for product labelling and promotional materials Experience with electronic content management systems and regulatory SOPs Excellent project management and organizational abilities Outstanding written and verbal communication skills Proven ability to work effectively in cross-functional teams Fluent in English, written and spoken
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Regulatory Affairs Specialist_Temporary Replacement
hace 1 semana
Alcobendas, España Italfarmaco España A tiempo completoJOB DESCRIPTION: Consulte la descripción del puesto a continuación. Si confía en que tiene las habilidades y la experiencia adecuadas, envíe su solicitud hoy mismo. Responsible for supporting global regulatory submissions and maintaining compliance with regulatory requirements for pharmaceutical products across multiple regions aligned with global...
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Regulatory Affairs Specialist_Temporary Replacement
hace 2 semanas
Alcobendas, España Italfarmaco España A tiempo completoJOB DESCRIPTION: Consulte la descripción del puesto a continuación. Si confía en que tiene las habilidades y la experiencia adecuadas, envíe su solicitud hoy mismo. Responsible for supporting global regulatory submissions and maintaining compliance with regulatory requirements for pharmaceutical products across multiple regions aligned with global...
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Regulatory Affairs Specialist_Temporary Replacement
hace 2 semanas
Alcobendas, España Italfarmaco España A tiempo completoJOB DESCRIPTION: Consulte la descripción del puesto a continuación. Si confía en que tiene las habilidades y la experiencia adecuadas, envíe su solicitud hoy mismo. Responsible for supporting global regulatory submissions and maintaining compliance with regulatory requirements for pharmaceutical products across multiple regions aligned with global...
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Regulatory Affairs Specialist_Temporary Replacement
hace 1 semana
Alcobendas, España Italfarmaco España A tiempo completoJOB DESCRIPTION: Responsible for supporting global regulatory submissions and maintaining compliance with regulatory requirements for pharmaceutical products across multiple regions aligned with global regulatory strategies. This role involves preparing regulatory dossiers, coordinating with health authorities, ensuring product registration, and providing...
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Alcobendas, España Italfarmaco España A tiempo completoJOB DESCRIPTION: Responsible for supporting global regulatory submissions and maintaining compliance with regulatory requirements for pharmaceutical products across multiple regions aligned with global regulatory strategies. This role involves preparing regulatory dossiers, coordinating with health authorities, ensuring product registration, and providing...
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MDM Senior Consultant
hace 7 días
Alcobendas, Madrid, España Eraneos Iberia A tiempo completoRol: Senior MDM ConsultantCantidad: 2 posicionesSeniority: SeniorTecnologías principales: IBM InfoSphere MDM (Product Master V14), JavaModalidad: Perfil híbrido (MDM + desarrollo + integraciones)Dentro de un importante proyecto internacional, en formato híbrido, estamos buscando este rol que nos ayude a configurar la base de datos de este gran...
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Senior SAP Authorization Consultant — Hybrid
hace 3 días
Alcobendas, España Sika AG A tiempo completoA global leader in construction solutions is looking for a Senior Consultant SAP Authorization in Madrid-Alcobendas. The role involves supporting SAP products, maintaining authorization concepts, and optimizing the user lifecycle. Ideally, candidates should have a degree in Computer Science, 5 years of relevant experience, and fluency in English and Spanish....
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alcobendas, España Sika AG A tiempo completoA global leader in construction solutions is seeking a highly technical Senior Consultant SAP Order-to-Cash in Madrid-Alcobendas. You will lead projects, design solutions, and manage application support activities within a global team. The ideal candidate will have 4-6 years of experience in configuring Order-to-Cash solutions, possess strong SAP integration...
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Senior Technology Quality Auditor
hace 7 días
Alcobendas, España Parexel A tiempo completoWhen our values align, there's no limit to what we can achieve. Technology Auditors possess significant authority and decision-making power within clinical trials. They autonomously assess technology, data integrity practices, and regulatory compliance, recommending necessary changes to ensure adherence to standards when deviations or non-compliance are...
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Consultor Reporting Regulatorio Banca
hace 2 semanas
Poligono Industrial Alcobendas, España Winning A tiempo completoDesde Winning estamos incorporando Consultores Junior, Senior para incorporarse en proyecto en importante empresa del sector financiero: As a Regulatory Reporting Analyst, you will perform Controls, floow up meetings and KPIs ensuring appropiate compliance for different Regulations. We need someone like you to help us in different fronts: - ** Analyze...
