Regulatory Affairs Consultant
hace 1 semana
When our values align, there's no limit to what we can achieve. Are you an experienced regulatory affairs professional looking for a new opportunity? We are currently seeking a talented Regulatory Affairs Consultant to join our dynamic team This is a client dedicated project, and the role can be office or home based in various European locations. As the Regulatory Affairs Consultant you will play a vital role in our company's worldwide post-approval regulatory activities, specifically focused on Chemistry, Manufacturing, and Controls (CMC) for biological products. Responsibilities Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports. Assess change controls and provide regulatory assessments of quality changes in production and quality control. Review study reports from the quality control and production departments to ensure compliance with regulatory requirements. Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies. Write and / or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities. Manage projects within all Regulatory Information Management systems, ensuring the maintenance of worldwide submissions. Identify, escalate, and mitigate risks associated with regulatory procedures and activities. Experience and Knowledge Requirements University-level education, preferably in Life Sciences, or equivalent by experience. Previous experience in regulatory affairs, particularly related to technical / CMC / quality, within the pharmaceutical industry. Strong understanding of CMC and post-approval regulatory requirements. Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations. Knowledge of biological processes. Background in validation / Quality Assurance / production in the pharmaceutical industry, with experience in preparing regulatory documentation. Understanding of qualification / validation principles. Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued. Team spirit, flexibility, accountability, and organizational skills. Fluent in English (written and spoken). #J-18808-Ljbffr
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Milano, España Parexel A tiempo completoA global biopharmaceutical consulting firm is seeking an experienced Regulatory Affairs Consultant to support worldwide post-approval regulatory activities, especially in Chemistry, Manufacturing, and Controls (CMC). This role offers flexibility in location, allowing office or home-based work across Europe. The ideal candidate will have a strong background...
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Junior Regulatory Affairs Specialist
hace 1 semana
Milano, España Amway Inc. A tiempo completoAmway is the world’s #1 direct selling company and one of the largest family-owned businesses globally. Since 1959, we’ve been empowering people with innovative solutions and over 450 premium products in nutrition, beauty, and home care. Sold exclusively through our network of independent distributors and our webshop, our products help millions live...
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Regulatory Affairs Associate – Global Health
hace 1 semana
Milano, España Amway Inc. A tiempo completoA multinational direct selling company based in Italy is seeking a Regulatory Affairs Specialist to manage product registration and compliance with legislation. The role involves preparing documentation, interacting with regulatory agencies, and providing support regarding legislative changes. Candidates should have a degree in Chemistry, Biology, or a...
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Stage - Area Sviluppo Prodotto - Regulatory Affairs
hace 1 semana
Milano, España Fulgard A tiempo completoStage Area Sviluppo Prodotto – Regulatory Affairs Intern Ricerchiamo una risorsa da inserire in stage nel Team di Sviluppo Prodotto nella sede di Milano per il ruolo di Regulatory Affairs Intern. Attività previste Supporto documentale e normativo: raccolta, revisione e archiviazione della documentazione tecnica necessaria al PIF (Product Information...
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Regulatory Affairs Intern – Product Development
hace 1 semana
Milano, España MEDSPA Srl A tiempo completoUn'azienda nel settore cosmetico, con sede a Milano, cerca un Regulatory Affairs Intern. Il candidato supporterà la raccolta e revisione della documentazione e garantirà la conformità normativa. È richiesta una laurea in settori come Farmacia o Chimica e buone capacità organizzative. Il tirocinio di 6 mesi offre un contesto dinamico e percorsi di...
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Stage Regulatory Affairs – Sviluppo Prodotto
hace 1 semana
Milano, España MEDSPA Srl A tiempo completoUn'azienda cosmetica in crescita cerca un/una stagista in Regulatory Affairs presso la sede di Milano. Il candidato ideale ha una laurea in Farmacia o disciplina affine e una buona conoscenza della normativa cosmetica. Le principali attività includono supporto nella documentazione, verifica della conformità e monitoraggio delle normative. Offriamo un...
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Stage - Area Sviluppo Prodotto - Regulatory Affairs
hace 1 semana
Milano, España MEDSPA Srl A tiempo completoRicerchiamo una risorsa da inserire in stage nel Team di Sviluppo Prodotto nella sede di Milano per il ruolo di Regulatory Affairs Intern.Attività previsteSupporto documentale e normativo: raccolta, revisione e archiviazione della documentazione tecnica necessaria al PIF (Product Information File).Verifica delle schede tecniche e delle SDS (Safety Data...
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Stage - Area Sviluppo Prodotto - Regulatory Affairs
hace 1 semana
Milano, España MEDSPA Srl A tiempo completoRicerchiamo una risorsa da inserire in stage nel Team di Sviluppo Prodotto nella sede di Milano per il ruolo di Regulatory Affairs Intern. Attività previste Supporto documentale e normativo: raccolta, revisione e archiviazione della documentazione tecnica necessaria al PIF (Product Information File). Verifica delle schede tecniche e delle SDS (Safety Data...
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Milano, España CPL & Taylor by Synergos Srl A tiempo completoCPL & TAYLOR by Synergos , ricerca :JUNIOR DIGITAL REGULATORY CONSULTANTLIFE SCIENCES(Rif. ANN417598)SEDE DI LAVORO : Si valutano profili provenienti da Verona, Milano, RomaCONTRATTO : Tempo indeterminato, full timeRETRIBUZIONE : da concordareL’aziendaImportante realtà internazionale specializzata in consulenza e soluzioni digitali per il settore Life...
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EU Labelling Regulatory Lead — Cross-Functional
hace 1 semana
Milano, España Parexel A tiempo completoA leading regulatory affairs company is seeking an experienced Regulatory Affairs professional to join as a European Labelling & Promotional Regulatory Specialist. This role involves managing EU product information, ensuring compliance with labelling regulations, and collaborating with cross-functional teams. The ideal candidate will have a degree in life...
