Regulatory Affairs Professional
hace 2 días
When our values align, there's no limit to what we can achieve. We are seeking a dedicated Regulatory Affairs Labelling professional to join our growing team This role offers an opportunity to work with global labelling teams, ensuring regulatory compliance and supporting product labelling management across multiple regions. The role can be home or office based in various European locations. Role Responsibilities: Support Global Labelling, Regulatory (Clinical/Safety), or Medical Writing teams for labelling updates Manage Company Core Datasheet (CCDS) implementation into labelling and artworks Identify triggers for CCDS updates and coordinate impact assessments for technical changes Apply knowledge of Safety Signal Management and its impact on labelling Navigate CCDS governance processes in pharmaceutical environments Understand Periodic Safety Update Reports (PSUR) and their potential impact on labelling Manage the relationship between labelling and artwork processes Implement regulatory processes required to update product labelling (various variation categories) Prepare Addendum to Clinical Overview (Module 2.5) to support labelling variations Apply regulatory requirements for labelling updates across different regions (EU, EAEU, US, APAC) Manage SmPC, PIL and QRD requirements, EU linguistic reviews, and translation activities Coordinate readability and PIL testing processes Review and approve consumer-facing materials in accordance with approved labelling Participate in promotion review committees and provide regulatory guidance for local markets Provide technical and business consulting services within area of expertise Complete activities within project scope, timeline, and objectives Skills and Experience required for the role: University Degree in a Scientific or Technical Discipline Initial years of labelling/regulatory experience with global responsibilities Regulatory Operations (Submission management) experience Outstanding interpersonal and intercultural communication skills (written and verbal) Critical thinking and problem-solving abilities Fluent in English, written and spoken
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Regulatory Affairs Manager
hace 2 semanas
Madrid, España Cpl Life Sciences A tiempo completoDirect message the job poster from Cpl Life SciencesManaging Consultant - Regulatory Affairs & Quality @ Cpl Life Sciencesob Title: European Regulatory Affairs ManagerLocation: Madrid, Spain, HybridRemuneration: Competitive salary and packageRegulatory Affairs Manager opportunity working for an established pharmaceutical company that specialises in generic,...
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Regulatory Affairs Manager
hace 7 días
Madrid, España Cpl Life Sciences A tiempo completoDirect message the job poster from Cpl Life SciencesPara una comprensión completa de esta oportunidad y de lo que se requerirá para ser un candidato exitoso, siga leyendo.Managing Consultant - Regulatory Affairs & Quality @ Cpl Life Sciencesob Title:European Regulatory Affairs ManagerLocation:Madrid, Spain, HybridRemuneration:Competitive salary and...
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Regulatory Affairs Manager
hace 3 semanas
Madrid, España Cpl Life Sciences A tiempo completoob Title:European Regulatory Affairs Manager Location:Madrid, Spain, Hybrid Regulatory Affairs Manager opportunity working for an established pharmaceutical company that specialises in generic, OTC, and prescription medicines. The business is increasingly growing and is looking for a personable and detail-oriented professional to join the small team and lead...
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Regulatory Affairs Manager
hace 2 semanas
Madrid, España Cpl Life Sciences A tiempo completoob Title: European Regulatory Affairs Manager Location: Madrid, Spain, Hybrid Remuneration: Competitive salary and package Regulatory Affairs Manager opportunity working for an established pharmaceutical company that specialises in generic, OTC, and prescription medicines. The business is increasingly growing and is looking for a personable and...
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Regulatory Affairs Manager
hace 2 semanas
Madrid, España Cpl Life Sciences A tiempo completoob Title: European Regulatory Affairs Manager ¿Es usted el solicitante adecuado para esta oportunidad? Descúbralo leyendo el resumen del puesto a continuación. Location: Madrid, Spain, Hybrid Remuneration: Competitive salary and package Regulatory Affairs Manager opportunity working for an established pharmaceutical company that specialises in generic,...
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Regulatory Affairs Manager
hace 2 semanas
Madrid, España Cpl Life Sciences A tiempo completoob Title: European Regulatory Affairs Manager Usted podría ser el solicitante perfecto para este trabajo. Lea toda la información asociada y asegúrese de presentar su candidatura. Location: Madrid, Spain, Hybrid Remuneration: Competitive salary and package Regulatory Affairs Manager opportunity working for an established pharmaceutical company that...
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Regulatory Affairs Manager
hace 2 semanas
Madrid, España Cpl Life Sciences A tiempo completoob Title: European Regulatory Affairs ManagerLocation: Madrid, Spain, HybridRemuneration: Competitive salary and packageRegulatory Affairs Manager opportunity working for an established pharmaceutical company that specialises in generic, OTC, and prescription medicines. The business is increasingly growing and is looking for a personable and detail-oriented...
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Regulatory Affairs Manager
hace 2 semanas
Madrid, España Cpl Life Sciences A tiempo completoob Title: European Regulatory Affairs ManagerAsegúrese de enviar su solicitud rápidamente para maximizar sus posibilidades de ser considerado para una entrevista. Lea la descripción completa del puesto a continuación.Location: Madrid, Spain, HybridRemuneration: Competitive salary and packageRegulatory Affairs Manager opportunity working for an...
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Regulatory Affairs Manager
hace 2 semanas
Madrid, España Cpl Life Sciences A tiempo completoob Title: European Regulatory Affairs ManagerRecuerde revisar su CV antes de enviar la solicitud. Además, asegúrese de leer todos los requisitos relacionados con este puesto.Location: Madrid, Spain, HybridRegulatory Affairs Manager opportunity working for an established pharmaceutical company that specialises in generic, OTC, and prescription medicines....
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International Regulatory Affairs Manager
hace 2 semanas
Madrid, España Straumann Group A tiempo completo**International Regulatory Affairs Manager** Straumann Group is synonymous with premium quality, precision and innovation that deliver confidence in dentistry, backed by the world's largest scientific network. As a global leader in implant dentistry, we offer cutting-edge innovations that are considered industry benchmarks and disruptive technological...
