Regulatory Affairs Manager
1 settimana fa
Mission:Develop and execute regulatory strategies and plans to ensure compliance with applicable laws, regulations, and standards.Stay updated on changes in regulatory requirements and translate them into actionable steps for the organization.Regulatory affairs Manager is responsible for ensuring that every product their company sells meets relevant government legislation, and that patient safety and efficacy are at the forefront of business activities.Act as the critical liaison between their organisation, the products they sell and the regulatory authorities by applying their scientific, business and regulatory expertise.Main activities:Manage the registration of pharmaceutical products, as well as medical devices and API in your countries and regions.Support the maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information (concerning current, pending and future approvals and renewals)Provide regulatory expertise to scientists and senior management on new product development, and assist with the preparation and submission of regulatory documentationAssist in reviewing product and process documentation for assigned projects to ensure compliance with requirements, as well as monitor renewals to strict deadlinesAct as liaison between multiple project teams to obtain significant information as well as answer queries that may ariseCommunicate design changes to existing products and company practices where necessaryPlan and develop product trials and interpret trial data, as well as take part in marketing activities for packaging or advertising approvalsStay up to date with the latest rules and regulationsGive presentations to regulatory authoritiesWrite appropriate standard harmonised regulatory affairs operating procedures for the companyCoordinate local compliance activities :impact assessment on local Change Control, define the local regulatory strategy for drug product communications, in compliance with local regulation.Requirements:Bachelor Degree in Life Science disciplines, preferably in Pharmacy/CTF/Biological Sciences/Chemistry.A specialisation in Regulatory Affairs is a plus.At least 5 years experience in regulatory field within pharmaceutical industry, preferably in companies with manufacturing sites for medical productsKnowledge of medicines legislation, GMP and reference guidelines.Experience with AIFA and AGES is prefered.Experience in using the various applications of the AIFA portal.Good communication skills – both written and verbalSkills of team working, critical thinking and planning, meeting deadlines efficiently.The ability to work under pressure and to tight deadlinesFluent in both spoken and written English.Fluency in another major European language is preferred.
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Regulatory Affairs Manager
6 giorni fa
milano, Italia Cpl Life Sciences A tempo pienoManaging 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...
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Global Regulatory Affairs Manager – Non-Pharma
7 giorni 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...
1 giorno fa
Milano, Italia Scienta A tempo pienoWe'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...
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Regulatory Affairs Manager
16 ore fa
Milano, Italia Whatjobs A tempo pienoMissionDevelop and execute regulatory strategies and plans to ensure compliance with applicable laws, regulations, and standards.Stay updated on changes in regulatory requirements and translate them into actionable steps for the organization.Regulatory affairs Manager is responsible for ensuring that every product their company sells meets relevant...
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Regulatory Affairs Manager
3 settimane fa
Milano, Italia Whatjobs A tempo pienoMission Develop and execute regulatory strategies and plans to ensure compliance with applicable laws, regulations, and standards. Stay updated on changes in regulatory requirements and translate them into actionable steps for the organization. Regulatory affairs Manager is responsible for ensuring that every product their company sells meets relevant...
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Regulatory Affairs Manager
3 settimane fa
Milano, Italia Whatjobs A tempo pienoMission Develop and execute regulatory strategies and plans to ensure compliance with applicable laws, regulations, and standards. Stay updated on changes in regulatory requirements and translate them into actionable steps for the organization. Regulatory affairs Manager is responsible for ensuring that every product their company sells meets relevant...
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Regulatory Affairs Manager
6 giorni 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 giorni fa
Milano, Italia HAYS A tempo pienoAzienda Multinazionale - Principi Attivi Farmaceutici - CDMO - Regulatory Affairs Manager - Affari Regolatori **La tua nuova azienda** Il nostro cliente è una realtà leader mondiale nella produzione e distribuzione di principi attivi farmaceutici e materie prime di originale naturale. In ottica di ampliamento dell’organico, siamo alla ricerca di una...
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Medical Device
7 giorni fa
Milano, Italia Resourcing Group A tempo pienoMedical Device – Regulatory Affairs DirectorResponsibilitiesLine management of 10 Regulatory Line ManagersEstablish and implement regulatory strategies ensuring new and existing products comply with the latest global requirementsTrain the team on EMEA / FDA requirementsQualificationsMinimum 8 years in regulatory affairs in the medical device...
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Medical Device
6 giorni fa
milano, Italia Altro A tempo pienoMedical Device – Regulatory Affairs DirectorResponsibilitiesLine management of 10 Regulatory Line ManagersEstablish and implement regulatory strategies ensuring new and existing products comply with the latest global requirementsTrain the team on EMEA / FDA requirementsQualificationsMinimum 8 years in regulatory affairs in the medical device...
