Regulatory Manager
hace 3 meses
.Precision for Medicine (CRO) are recruiting a Regulatory Manager to join our team, candidates can be based in the following countries: UK, Spain, Hungary, Slovakia, Serbia, Romania or Poland.Position Summary:The Regulatory Manager (RM) provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ensuring timely preparation of well organized, quality regulatory submissions in compliance with applicable regulations. The RM coordinates and prepares regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, as applicable. The RM maintains a current knowledge of regulations and guidance documents, providing analysis to project teams, as well as supporting and enhancing Precision for Medicines corporate Regulatory function.Essential functions of the job include but are not limited to:Provides regulatory guidance throughout the clinical development life cycleCompile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications. Also provides strategic regulatory input as requiredDevelops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standardsServe as representative of Global Regulatory Affairs at project team meetings with both external and internal customersWorks within a project team, and where necessary, leads project for the region or globallyOversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programsMaintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.Assist in development of Regulatory Affairs Specialists and other operational area staff, as requiredProvide input, as required, into regulatory strategy and timeline development for new study opportunities Assists in establishing company standards to ensure the highest quality of submitted informationParticipates in maintaining and executing on the corporate quality initiatives across business units within clinical solutions
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Regulatory Compliance Manager
hace 2 semanas
Madrid, Madrid, España Dojo 2022 A tiempo completoAbout the RoleThe Dojo 2022 team is seeking a highly skilled Regulatory Compliance Manager to join our expanding European operations. As a key member of our compliance team, you will play a critical role in ensuring our business practices align with regulatory requirements and industry standards.Key ResponsibilitiesAdvisory Services: Provide expert guidance...
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Regulatory Compliance Manager
hace 2 semanas
Madrid, Madrid, España Dojo 2022 A tiempo completoAbout the RoleThe Dojo 2022 team is seeking a highly skilled Regulatory Compliance Manager to join our expanding European operations. As a key member of our compliance team, you will play a critical role in ensuring our business practices align with regulatory requirements and industry standards.Key ResponsibilitiesAdvisory Services: Provide expert guidance...
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Regulatory Manager
hace 4 meses
Madrid, España Ebury A tiempo completoEbury is a hyper-growth FinTech firm, named in 2021 as one of the top FinTechs to work for by Glassdoor and AltFi. We offer a range of products including FX risk management, trade finance, currency accounts, international payments and API integration. **Regulatory Reporting Manager - 2LoD** Madrid (Office based) As a Regulatory Reporting Manager - 2LoD...
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Regulatory Manager
hace 3 meses
Madrid, España INSUD PHARMA, S.L.U. A tiempo completoOverview: **General Responsibility** The Manager, Regulatory Affairs CMC is responsible for defining and implementing global CMC strategies including regulatory relevant technical guidance to development teams and ensures adequacy of CMC documentation for global regulatory submissions. The position supports and promotes all regulatory CMC tasks throughout...
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Regulatory Manager
hace 2 semanas
Madrid, España Jr Spain A tiempo completocol-wideJob Description:Overview:**General Responsibility**The Manager, Regulatory Affairs CMC is responsible for defining and implementing global CMC strategies including regulatory relevant technical guidance to development teams and ensures adequacy of CMC documentation for global regulatory submissions. The position supports and promotes all regulatory...
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Regulatory Affairs Manager
hace 1 semana
Madrid, España Mcr International A tiempo completoLAR-2409-288REGULATORY AFFAIRS MANAGERMADRIDFrom MCR International , we are looking for a Regulatory Affairs Manager with a proven track record in the agrochemicals industry . If you are looking to join a fast-growing company with a strong vision and a collaborative culture, this is your opportunity. This role could be based in Spain, ideally located in...
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Regulatory Manager
hace 4 meses
Madrid, España Precision for Medicine A tiempo completoPosition Summary: The Regulatory Manager (RM) provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ensuring timely preparation of well organized, quality regulatory submissions in compliance with applicable regulations....
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Regulatory Affairs Manager
hace 6 días
Madrid, España Mcr International A tiempo completoLAR-2409-288REGULATORY AFFAIRS MANAGERMADRIDFrom MCR International, we are looking for a Regulatory Affairs Manager with a proven track record in the agrochemicals industry. If you are looking to join a fast-growing company with a strong vision and a collaborative culture, this is your opportunity. This role could be based in Spain, ideally located in Madrid...
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Regulatory Compliance Manager
hace 1 mes
Madrid, España Dojo 2022 A tiempo completo.The RoleAs we start our expansion into Europe, we are looking for a Local Regulatory Compliance Officer, who will own Dojo's regulatory compliance programme for Spain; establishing and maintaining a robust compliance framework aligned with regulatory requirements and standards set by the Banco de España.Reporting into the Head of Regulatory Compliance for...
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Regulatory Compliance Manager
hace 2 semanas
Madrid, Madrid, España Zentiva Group, a.s. A tiempo completoJoin Zentiva Group, a.s. as we seek a Regulatory Compliance Manager to oversee our regulatory initiatives at the national level. This is a pivotal role where you will manage the Regulatory Compliance framework within the country. Your primary responsibilities will encompass:Delivering a proactive and efficient Regulatory service aligned with business...
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Regulatory Compliance Manager
hace 1 mes
Madrid, Madrid, España Zentiva Group, a.s. A tiempo completoJoin Zentiva Group, a.s. as we seek a Regulatory Compliance Manager to oversee our regulatory initiatives at the national level. This is a pivotal role where you will manage the Regulatory Compliance framework within the country. Your primary responsibilities will encompass:Delivering a proactive and efficient Regulatory service aligned with business...
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Regulatory Writing Manager
hace 1 semana
Madrid, Madrid, España Icon A tiempo completoJob SummaryWe are seeking a highly skilled and experienced Regulatory Writing Manager to join our team at ICON. As a key member of our medical writing department, you will be responsible for overseeing the development of high-quality regulatory documents and ensuring compliance with relevant guidelines and regulations.About the RoleLead a team of medical...
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Regulatory Writing Manager
hace 1 semana
Madrid, Madrid, España Icon A tiempo completoJob SummaryWe are seeking a highly skilled and experienced Regulatory Writing Manager to join our team at ICON. As a key member of our medical writing department, you will be responsible for overseeing the development of high-quality regulatory documents and ensuring compliance with relevant guidelines and regulations.About the RoleLead a team of medical...
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Regulatory Compliance Manager
hace 2 semanas
Madrid, España Ebury A tiempo completoEbury is a hyper-growth FinTech firm, named in as one of the top 15 European Fintechs to work for by AltFi.We offer a range of products including FX risk management, trade finance, currency accounts, international payments and API integration.Regulatory Compliance Manager - EEA Madrid Office - Hybrid: 4 days in the office, 1 day working from homeDepartment:...
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Regulatory Compliance Manager
hace 4 semanas
Madrid, España Dojo 2022 A tiempo completoThe RoleAs we start our expansion into Europe, we are looking for a Local Regulatory Compliance Officer, who will own Dojo's regulatory compliance programme for Spain; establishing and maintaining a robust compliance framework aligned with regulatory requirements and standards set by the Banco de España.Reporting into the Head of Regulatory Compliance for...
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Regulatory Affairs Manager
hace 2 semanas
Madrid, Madrid, España Innovaderm Research A tiempo completoJob DescriptionJob Title: Regulatory Affairs ManagerJob Summary:Innovaderm Research is seeking a highly experienced Regulatory Affairs Manager to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring that our services are conducted in accordance with Innovaderm's standard operating procedures, applicable...
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Regulatory Affairs Manager
hace 2 semanas
Madrid, Madrid, España Innovaderm Research A tiempo completoJob DescriptionJob Title: Regulatory Affairs ManagerJob Summary:Innovaderm Research is seeking a highly experienced Regulatory Affairs Manager to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring that our services are conducted in accordance with Innovaderm's standard operating procedures, applicable...
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Regulatory Compliance Manager
hace 2 semanas
Madrid, Madrid, España Dojo 2022 A tiempo completoAbout the RoleWe are seeking a highly skilled Regulatory Compliance Manager to join our team at Dojo 2022. As a key member of our compliance function, you will play a critical role in ensuring that our business operations are in line with regulatory requirements and industry standards.The successful candidate will be responsible for providing expert advice...
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Regulatory Compliance Manager
hace 2 semanas
Madrid, Madrid, España Dojo 2022 A tiempo completoAbout the RoleWe are seeking a highly skilled Regulatory Compliance Manager to join our team at Dojo 2022. As a key member of our compliance function, you will play a critical role in ensuring that our business operations are in line with regulatory requirements and industry standards.The successful candidate will be responsible for providing expert advice...
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Regulatory Compliance Manager
hace 1 mes
Madrid, Madrid, España Zentiva Group, a.s. A tiempo completoJoin Zentiva Group, a.s. as we seek a Regulatory Compliance Manager to oversee our regulatory agenda at the national level. This is a pivotal role where you will be tasked with steering the Regulatory Affairs initiatives within the country. Your primary responsibilities will encompass:Delivering a proactive and efficient Regulatory service to align with...
