Regulatory Affairs Manager
19 ore fa
We're currently partnering with a leading global consumer health business to find an experienced Global Regulatory Operations Medicine Manager to join their dynamic Regulatory Affairs team.This is an exciting opportunity to lead end-to-end regulatory operations across a diverse portfolio of over-the-counter (OTC) and consumer health products.You'll be working at the heart of a fast-paced, innovation-driven environment, driving dossier strategy, managing global submissions, and collaborating closely with cross-functional teams across markets.Responsibilities:Lead Regulatory Submissions: Oversee the planning, preparation, and timely submission of regulatory documentation (e.g., e CTD Modules 1–5) for product registrations, variations, renewals, and withdrawals, ensuring accuracy and compliance.Coordinate Stakeholder Engagement: Serve as the primary regulatory contact for designated product categories (e.g., analgesics), fostering effective communication with internal teams and external partners.Maintain Dossier Integrity: Manage the creation and upkeep of core product dossiers, ensuring alignment with current regulatory requirements and submission timelines.Ensure Documentation Readiness: Supervise the organisation and electronic archiving of regulatory records to support accessibility and inspection readiness.Collaborate Across Functions: Work cross-functionally with Regulatory Strategy, R& D, Pharmacovigilance, Quality, and Marketing to ensure regulatory alignment throughout the product lifecycle.Requirements:Degree in Pharmacy, Life Sciences, or a closely related field (Bachelor's or Master's level).At least 5 years of hands-on experience in regulatory affairs within the pharmaceutical or healthcare sector.Strong command of international regulatory guidelines (e.g., EMA, ICH, and national health authorities).Solid track record in preparing and submitting e CTD dossiers, including CMC M3 content development.Highly organised with excellent attention to detail and ability to manage multiple regulatory projects simultaneously.
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Regulatory Affairs Manager
2 settimane fa
Milano, Lombardia, Italia Bayer A tempo pienoAt 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...
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Regulatory Affairs Manager
5 giorni fa
Milano, Lombardia, Italia Option One Life Science Consulting Sagl A tempo pienoRegulatory Affairs Manager | Clinical Development (CTA/IND) | EU/US/RoWABOUT / INFORegulatory Affairs professional with years of experience in the pharmaceutical industry, supporting global clinical development programs across EU, US and RoW. Strong track record in managing clinical trial applications and maintenance activities (CTA/IND), coordinating...
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Regulatory Affairs Manager
2 settimane fa
Milano, Lombardia, Italia Bayer A tempo pienoAt 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...
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Global Regulatory Affairs Manager – Non-Pharma
4 settimane fa
Milano, Italia Alfasigma A tempo pienoA global healthcare company is seeking a Non-Pharma Global Regulatory Affairs Manager based in Milan. The role involves managing regulatory documentation, executing global regulatory strategies, and ensuring compliance for non-pharma products. Candidates should have proven experience in Regulatory Affairs, a background in life sciences, and strong...
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Regulatory Affairs Manager
2 settimane fa
Milano, Italia AGC Biologics A tempo pieno**Agc Biologics, leader company in Cell & Gene Therapy field, is looking for a Regulatory Affairs Manager** **Main Responsabilities**: - Support the customers in regulatory dossier filing, including the revision of the CMC documents for regulatory submissions and the answer to Competent Authority requirements; - Coordinate and collect information from...
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Regulatory affairs manager
2 settimane fa
Milano, Lombardia, Italia The Human Factor A tempo pienoPer azienda cliente, realtà attiva nello sviluppo e nella produzione di farmaci, dispositivi medici, cosmetici e integratori, con un forte orientamento alla qualità e all'innovazione, siamo alla ricerca di un/una:Regulatory Affairs ManagerLa figura avrà un ruolo centrale nel garantire la conformità normativa dei prodotti lungo tutto il loro ciclo di...
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Regulatory Affairs Manager
7 giorni fa
Milano, Italia ICON A tempo pienoAt ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...
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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...
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Regulatory Affairs Project Manager
2 settimane fa
milano, Italia ADAMA Ltd. A tempo pieno1 day ago Be among the first 25 applicantsJoin ADAMA – A Global Leader in Crop Protection shaping the future of agricultureWith nearly 10,000 employees and $5 billion in annual sales across more than 100 countries, ADAMA is one of the world’s top crop protection companies and part of the Syngenta Group. Our mission is to create simplicity in agriculture...
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Regulatory Affairs Project Manager
20 ore fa
Milano, Italia Adama Ltd. A tempo pieno1 day ago Be among the first 25 applicantsJoin ADAMA – A Global Leader in Crop Protection shaping the future of agricultureWith nearly 10,000 employees and $5 billion in annual sales across more than 100 countries, ADAMA is one of the world's top crop protection companies and part of the Syngenta Group.Our mission is to create simplicity in agriculture –...
