Empleos de fda en Madrid

IES Medical busca un/a Regulatory Affairs Specialist/Senior Specialist para un entorno técnico e internacional. Reporta a Dirección de Operaciones – Calidad y colabora con Dirección Médica, gestionando el SGC y la conformidad regulatoria.Se espera experiencia en auditorías MDR/FDA, elaboración de expedientes y capacidad de autonomía. Contrato...

Importante Multinacional Farmacéutica, situada en Sant Cugat del Vallés precisa incorporar a su equipo:PROCESS EXPERT (Compounding)La persona seleccionada será responsable de liderar técnicamente la preparación, transferencia, puesta en marcha y consolidación de los procesos de producción aséptica, garantizando el cumplimiento de los estándares GMP,...

Adeas Hr busca un EXPERTO DE PROCESOS (Compounding) para liderar, transferir y poner en marcha procesos estériles de producción en una multinacional farmacéutica con foco en GMP y FDA. Coordinará lotes técnicos, media fills y actividades de transferencia, asegurando cumplimiento y documentación GMP durante todo el proyecto.El candidato ideal tiene 5+...

Roche Madrid is seeking a Delivery Service Manager to own end-to-end service delivery for mission-critical IT services enabling cell and gene therapy operations. You will lead governance, apply Agile practices, and drive continuous improvement while coordinating with diverse stakeholders in a global environment. The role requires 5+ years in delivery...

Boehringer Ingelheim, empresa biotecnológica líder, busca un profesional para el departamento de QA Systems Product en Sant Cugat del Vallès. La función implica garantizar el cumplimiento GMP y la gestión de validaciones y documentación maestra, así como la revisión de métodos analíticos y lotes.Se requiere más de 5 años de experiencia en la...

Headhuntersmx busca un/a Gerente de Comercio Electrónico Senior para liderar la estrategia de Amazon en la categoría de suplementos alimenticios. La posición es 100% presencial en Guadalajara, con enfoque en crecimiento de ventas, rentabilidad de campañas PPC y posicionamiento orgánico.Se requieren al menos 3 años gestionando cuentas de Amazon Seller...

Thermo Fisher Scientific in Spain is seeking a Clinical Trial Manager to oversee operational and quality aspects of studies, ensuring timely delivery within contract scope and leading cross-functional teams.You will develop clinical plans, coordinate start-up activities, monitor budgets, and ensure compliance with ICH GCP and FDA guidelines, with frequent...

Veeva Systems is seeking an experienced consultant to lead MedTech Complaints implementations globally, guiding transformation of customers’ complaints management processes and technology.The role, a remote, full-time position based in the EU or UK, requires deep knowledge of Complaints Management in Medical Devices, FDA EU MDR/IVDR, and SaaS-based quality...

INSUD PHARMA busca un/a Técnico/a Senior de Formulación y Desarrollo Farmacéutico para su planta en Azuqueca de Henares. Deberá supervisar formulaciones y procesos galénicos, preparar medicamentos para ensayos clínicos y gestionar la documentación regulatoria conforme GMP/GLP.Se valora experiencia en ambiente GMP, conocimiento de FDA y habilidades de...

Amaris Consulting, part of Mantu, is seeking a Biostatistician to contribute to data analysis, interpretation, and statistical studies across our projects. In this central role you will support strategic decision-making through rigorous analytics and clear reporting.You will work on SAP drafting, data processing, study reporting, and ensuring compliance with...

Mercor is seeking a Regulatory Law Expert to design and supervise regulatory compliance programs, including investigations and enforcement actions. The role covers financial services regulation, healthcare and FDA rules, antitrust and data privacy, cybersecurity, and environmental and energy regulation in a global setting.You will use regulatory tracking...

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to work within a sponsor-dedicated program for a pharmaceutical client. You will generate SDTM/ADaM specs, develop SAS and R programs, and oversee CRO deliverables.The role emphasizes independence, regulatory compliance, and delivering high-quality analyses for multiple studies....

Werfen Immunoassay seeks an Regulatory Affairs Lead to provide regulatory support for our products and our customers. You will prepare and submit documentation according to country legislation and implement new regulatory requirements.Responsibilities include CE/FDA registrations, maintaining technical files, reviewing materials for compliance, supporting...

Importante Multinacional Farmacéutica, situada en Sant Cugat del Vallés precisa incorporar a su equipo:QA COMPLIANCE OFFICERComo parte de la estructura de Operaciones de Calidad y reportando directamente al responsable del grupo de QA Shopfloor – Aseptic, el/la QA Compliance Officer – Aseptic será responsable de apoyar los procesos de toma de...

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to join a sponsor-integrated program. You will work on clinical development programs across therapeutic areas, independently guiding CRO programmers and delivering high-quality SAS and R analyses for trials.You will generate SDTM/ADaM specifications and define.Xml, create datasets and...

IQVIA in Barcelona, Spain is seeking a Full-time FTE Medical Writer to develop clinical documents including CTRs, TDOs/CTPs, IBs, and submission materials. You will embed with sponsor teams, align on timelines, and ensure quality across trials in eye health and inflammation.The role requires a strong background in medical writing within biopharma or CRO,...

Precision Medicine Group is seeking a Senior Medical Writer/Principal Medical Writer to lead development of high-quality clinical study documents, plan writing, edit/format, and perform QC reviews in line with ICH, FDA, GCP and eCTD requirements.The role focuses on producing submissions across development stages, collaborating with sponsors, external...

Cytel is seeking a Senior/Principal Statistical Programmer for a fully remote role. You will work on clinical development programs, implementing SDTM/ADaM specifications and generating complex datasets, tables, and figures in SAS and R.You will also oversee CRO deliverables and contribute to regulatory submissions and exploratory analyses. The role requires...

Roche Holding AG sucht eine erfahrene Lead-Position im Bereich Computer System Validation (CSV) im CGT-Umfeld. Sie überwachen die Validierung digitaler Lösungen, stellen regulatorische Konformität sicher und arbeiten eng mit Produktmanagern, Entwicklern und Stakeholdern zusammen, um hochwertige pharmazeutische Produkte zuverlässig herzustellen.Sie...

Experteer Overview As an Associate Principal / Principal in COA Strategy, you lead the design and articulation of COA endpoint strategies across clinical programs, aligning science with regulatory expectations. You act as an external scientific leader, mentoring teams and shaping client solutions with patient-centered measurement science. You will engage...