Senior Regulatory Affairs Consultant

hace 2 semanas

Madrid, España Parexel A tiempo completo

OverviewWe 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 ResponsibilitiesEU 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 TCLP for early development assetsOperational 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 SPA for artwork and mock-up changes, participating in Change Control ProcessesLeadership & 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, SPA, and PLG teams Monitor changes in EMA labelling requirements and keep the organization informed of technology requirementsQualificationsUniversity 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#J-18808-Ljbffr

  • Regulatory Affairs Manager

    hace 3 días

    Madrid, España Cpl Life Sciences A tiempo completo

    Direct 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,...

  • Regulatory Affairs Manager

    hace 2 semanas

    Madrid, España Cpl Life Sciences A tiempo completo

    Direct message the job poster from Cpl Life SciencesManaging Consultant - Regulatory Affairs & Quality @ Cpl Life Sciences ob 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,...

  • Regulatory Affairs Manager

    hace 2 semanas

    Madrid, España Cpl Life Sciences A tiempo completo

    Direct message the job poster from Cpl Life Sciences Managing Consultant - Regulatory Affairs & Quality @ Cpl Life Sciences ob 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...

  • Senior Regulatory Affairs Technician

    hace 1 semana

    Madrid, España Attindas-SP A tiempo completo

    **Senior Regulatory Affairs Technician (Pozuelo, Madrid)**: ¿Tienes experiência en Regulatory Affairs en medical devices, cosmética o farma? ¿Buscas un nuevo reto en un entorno altamente regulado y en plena transformación? En **Attindas Hygiene Partners** buscamos un/a **Senior Regulatory Affairs Technician** para nuestro equipo en Pozuelo (Madrid). La...

  • Regulatory Affairs Manager

    hace 4 semanas

    Madrid, España Cpl Life Sciences A tiempo completo

    ob Title:European Regulatory Affairs ManagerLocation: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...

  • Regulatory Affairs Manager

    hace 1 semana

    Madrid, España Cpl Life Sciences A tiempo completo

    ob 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...

  • Regulatory Affairs Manager

    hace 1 semana

    Madrid, España Cpl Life Sciences A tiempo completo

    ob Title: European Regulatory Affairs ManagerLocation: Madrid, Spain, HybridRegulatory 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...

  • Regulatory Affairs Manager

    hace 5 días

    Madrid, España Cpl Life Sciences A tiempo completo

    ob 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....

  • Senior Regulatory Affairs Specialist

    hace 7 días

    Madrid, España Indero A tiempo completo

    The Senior Regulatory Affairs Specialist will provide leadership for assigned projects regarding all regulatory activities that lead to startup of clinical trials and will oversee global/multinational complex large clinical trial submissions. This role will be responsible for sponsor-facing regulatory leadership and management of regulatory deliverables...

  • Senior Manager

    hace 4 días

    Madrid, España Cpl Life Sciences A tiempo completo

    ob Title :European Regulatory Affairs ManagerLocation :Madrid, Spain, HybridRegulatory 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...