Regulatory Affairs Consultant
2 giorni fa
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.ResponsibilitiesDevelop 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 RequirementsUniversity-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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Regulatory Affairs Senior Consultant
2 settimane fa
Milan, Italia Altro A tempo pienoSei pronto per entrare a far parte di una società di consulenza leader mondiale nell'industria farmaceutica e dei Medical Device ? PQE Group è affermata in questo settore dal 1998 , garantendo una presenza internazionale grazie alle 45 filiali e i 2000 dipendenti in Europa, Asia e nelle Americhe.Lavorare in una realtà di consulenza come PQE Group ti...
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Regulatory Affairs Senior Consultant
2 settimane fa
Milan, Italia Altro A tempo pienoSei pronto per entrare a far parte di una società di consulenza leader mondiale nell'industria farmaceutica e dei Medical Device ? PQE Group è affermata in questo settore dal 1998 , garantendo una presenza internazionale grazie alle 45 filiali e i 2000 dipendenti in Europa, Asia e nelle Americhe.Lavorare in una realtà di consulenza come PQE Group ti...
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Global Regulatory Affairs Senior Consultant
2 settimane fa
Milan, Italia Altro A tempo pienoUna società di consulenza leader nel settore farmaceutico cerca un Regulatory Affairs Senior Consultant a Milano. Il candidato ideale possiede 4-5 anni di esperienza, una laurea in discipline scientifiche e solide conoscenze delle normative globali. Offriamo un contratto a tempo indeterminato, retribuzione commisurata all'esperienza e un ambiente di lavoro...
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Regulatory Affairs Senior Consultant
2 giorni fa
Milan, Italia Altro A tempo pienoSei pronto per entrare a far parte di unasocietà di consulenza leader mondiale nell'industria farmaceutica e dei Medical Device ? PQE Group è affermata in questo settore dal1998 , garantendo una presenza internazionale grazie alle45 filialie i2000 dipendentiin Europa, Asia e nelle Americhe. Lavorare in una realtà di consulenza come PQE Group ti darà: La...
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Regulatory Affairs Manager
1 settimana fa
Milan, Italia Altro 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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Milan, Italia Altro A tempo pienoA 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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Regulatory Affairs Consultant
3 settimane fa
Milan, Italia Altro A tempo pienoWhen 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...
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Regulatory Affairs Consultant
2 settimane fa
Milan, Italia Parexel A tempo pienoWhen 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...
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Senior Regulatory Affairs consultant
2 settimane fa
Milan, Italia PQE Group A tempo pienoSei pronto per entrare a far parte di unasocietà di consulenza leader mondiale nell'industria farmaceutica e dei Medical Device ? PQE Group è affermata in questo settoredal 1998 , garantendo una presenza internazionale grazie alle45 filialie i2000 dipendentiin Europa, Asia e nelle Americhe.Lavorare in una realtà di consulenza come PQE Group ti darà :La...
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Regulatory Affairs Specialist
1 settimana fa
Milan, Italia Altro A tempo pienoOverviewJoin to apply for the Regulatory Affairs Specialist (L.68/99) role at AstraZenecaAre you ready to make a difference in the world of healthcare? As a Regulatory Affairs Specialist within the Italian Marketing Company, you will play a crucial role in achieving and maintaining regulatory authorizations for new and existing products. You will support the...
