Regulatory Affairs Professional

1 settimana fa

Milano, Italia Parexel A tempo pieno

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 teamThis 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 ResponsibilitiesSupport Global Labelling, Regulatory (Clinical / Safety), or Medical Writing teams for labelling updatesManage Company Core Datasheet (CCDS) implementation into labelling and artworksIdentify triggers for CCDS updates and coordinate impact assessments for technical changesApply knowledge of Safety Signal Management and its impact on labellingNavigate CCDS governance processes in pharmaceutical environmentsUnderstand Periodic Safety Update Reports (PSUR) and their potential impact on labellingManage the relationship between labelling and artwork processesImplement regulatory processes required to update product labelling (various variation categories)Prepare Addendum to Clinical Overview (Module 2.5) to support labelling variationsApply regulatory requirements for labelling updates across different regions (EU, EAEU, US, APAC)Manage SmPC, PIL and QRD requirements, EU linguistic reviews, and translation activitiesCoordinate readability and PIL testing processesReview and approve consumer-facing materials in accordance with approved labellingParticipate in promotion review committees and provide regulatory guidance for local marketsProvide technical and business consulting services within area of expertiseComplete activities within project scope, timeline, and objectivesSkills and Experience required for the roleUniversity Degree in a Scientific or Technical DisciplineInitial years of labelling / regulatory experience with global responsibilitiesRegulatory Operations (Submission management) experienceOutstanding interpersonal and intercultural communication skills (written and verbal)Critical thinking and problem-solving abilitiesFluent in English, written and spoken#J-*****-Ljbffr

  • Regulatory Affairs Professional

    2 settimane fa

    Milano, Italia Olon A tempo pieno

    Olon Group è leader globale nello sviluppo e nella produzione di principi attivi farmaceutici (API) per i mercati CDMO e generico, integrando sintesi chimica e processi biologici, rispettando sempre i più elevati standard internazionali di sicurezza, qualità e ambiente. Olon vanta una rete globale di 14 siti di produzione e 9 centri di R&S in tutto il...

  • Regulatory Affairs

    3 giorni fa

    Milano, Italia Page Personnel Italia A tempo pieno

    Regulatory Affairs |Dispositivi Medici Esperienza pregressa nel ruolo di 3/5 anni. Richiesta esperienza con prodotti quali integratori e dispositivi medici classe I o II Contratto a tempo indeterminato Azienda operante nel settore farmaceutico per la sede a Milano. Ottima opportunità di carriera con contratto a tempo indeterminato. Per società...

  • Regulatory Affairs Consultant

    2 settimane fa

    Milano, Italia HAYS A tempo pieno

    Società di Consulenza - Aziende Farmaceutiche - Affari Regolatori - Regulatory Affairs Consultant - Milano **La tua nuova azienda** Il nostro cliente è una rinomata Società di consulenza che fornisce servizi alle azienda farmaceutiche in merito alle autorizzazioni necessarie per la commercializzazione dei loro prodotti. In un’ottica di ampliamento...

  • Regulatory Affairs Specialist

    5 giorni fa

    Milano, Lombardia, Italia Ali Professional A tempo pieno

    Ali Professional ricercaper importante realtà internazionale del settore chimico-farmaceutico un/una:Regulatory Affairs SpecialistLa risorsa sarà inserita nel dipartimento Regulatory Affairs e sarà responsabile della gestione delle attività normative relative ai prodotti di propria competenza, assicurando la conformità alle procedure aziendali e alla...

  • Regulatory Affairs Manager

    4 giorni fa

    Milano, Italia Cpl Life Sciences A tempo pieno

    Managing Consultant - Regulatory Affairs & Quality @ Cpl Life Sciencesob Title:European Regulatory Affairs ManagerLocation:Milan, Italy - 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...

  • Regulatory Affairs Manager

    2 settimane fa

    milano, Italia Cpl Life Sciences A tempo pieno

    Managing Consultant - Regulatory Affairs & Quality @ Cpl Life Sciencesob Title: European Regulatory Affairs ManagerLocation: Milan, Italy - 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...

  • Regulatory Affairs Manager

    2 giorni fa

    Milano, Lombardia, Italia Bayer A tempo pieno

    At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and...

  • Regulatory Affairs Manager

    2 giorni fa

    Milano, Lombardia, Italia Bayer A tempo pieno

    At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and...

  • Regulatory Affairs Manager

    3 giorni fa

    Via Milano, Italia Cpl Life Sciences A tempo pieno

    Managing Consultant - Regulatory Affairs & Quality @ Cpl Life Sciencesob Title: European Regulatory Affairs ManagerLocation: Milan, Italy - 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...

  • Regulatory Affairs Specialist

    2 settimane fa

    Milano, Italia Lactalis Italia Srl A tempo pieno

    **Gruppo Lactalis Italia**è alla ricerca di un/a Regulatory Affairs Specialist da inserire all’interno della funzione Legale. La risorsa, supportando il Regulatory Affairs Manager, si occuperà di: - Assicurare l’aggiornamento normativo al fine di recepire le novità sia a livello italiano che europeo e veicolare le informazioni nel Gruppo...