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Regulatory Manager, Clinical Trials Regulatory Management- Home-Based, Emea
hace 3 semanas
.Prepares and / or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and programsRESPONSIBILITIESActs as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs and may act as a Regulatory Oversight for a key customerAbility to administratively and technically / scientifically review core scientific documentation and feedback gap analysis to customers.Ability to write scientific documents e.G. Investigational Medicinal Product Dossier, clinical trial justificationsMay strategically plan and perform European centralized submissions and facilitate global country submissions on complex studies or programsMay provide support on key regulatory business development opportunities and complete Data Informed Protocol Assessments (DIPAs)Understands the Scope of Work, deliverables and budget for any given project and ensure timelines are met.Ensures accurate completion, maintenance and adherence to internal systems, databases, tracking tools and project plans in line with agreed SOPs (customer and / or IQVIA)
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Regulatory Affairs Manager
hace 3 semanas
Madrid, España Worldwide Clinical Trials, Llc A tiempo completoRegulatory Affairs Manager - Europe - Home-based Worldwide Clinical Trials does not accept unsolicited resumes from 3rd party vendorsWe only accept resumes from staffing organizations with pre-approved contractual agreements. Please do not forward resumes directly to our hiring managers, jobs alias, or any other company location. Unsolicited resumes from...
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Regulatory Affairs Manager
hace 3 semanas
Madrid, España Worldwide Clinical Trials, Llc A tiempo completoRegulatory Affairs Manager - Europe - Home-basedWorldwide Clinical Trials does not accept unsolicited resumes from 3rd party vendorsWe only accept resumes from staffing organizations with pre-approved contractual agreements. Please do not forward resumes directly to our hiring managers, jobs alias, or any other company location. Unsolicited resumes from...
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Regulatory Affairs Manager
hace 2 semanas
Madrid, España Worldwide Clinical Trials, Llc A tiempo completoRegulatory Affairs Manager - Europe - Home-basedWorldwide Clinical Trials does not accept unsolicited resumes from 3rd party vendorsWe only accept resumes from staffing organizations with pre-approved contractual agreements. Please do not forward resumes directly to our hiring managers, jobs alias, or any other company location. Unsolicited resumes from...
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Madrid, España IQVIA A tiempo completoPrepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and programs RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs and may act as a Regulatory Oversight for a key customer Ability to...
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Madrid, España IQVIA A tiempo completoPrepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and programs RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs and may act as a Regulatory Oversight for a key customer Ability to...
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Regulatory Affairs Manager
hace 2 semanas
Madrid, España Worldwide Clinical Trials A tiempo completo**Requisition Number** **6658** **Employment Type***: **Regular** **Who we are** We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with...
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Madrid, España Sdi Digital Group A tiempo completoPrepares and / or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for more complex projects. RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on global projects which may be complexAbility to administratively and technically / scientifically review core scientific documentation...
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Regulatory Manager
hace 1 mes
Madrid, España Precision For Medicine A tiempo completoPrecision 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,...
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Regulatory Manager
hace 4 días
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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Sr / Regulatory Medical Writer - Certain Emea
hace 4 semanas
Madrid, España Thermo Fisher Scientific A tiempo completoAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...
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Sr / Regulatory Medical Writer - Certain Emea
hace 3 días
Madrid, España Thermo Fisher Scientific A tiempo completoAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...
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Sr / Regulatory Medical Writer - Certain Emea
hace 2 semanas
Madrid, España Thermo Fisher Scientific A tiempo completoAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...
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Regulatory Affairs Manager Emea/apac
hace 6 días
Madrid, España Blu Selection A tiempo completoOur client is looking for a dynamic and experienced Manager of Regulatory Affairs and Compliance to oversee the Regulatory Affairs functions for the EMEA and APAC regions. **Your Responsibilities and Impact as Regulatory Affairs Manager will be**: - Supervising Regulatory Affairs for EMEA and APAC jurisdictions, ensuring adherence to procedures and...
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Regulatory Affairs Manager
hace 3 semanas
Madrid, España Morgan Philips Executive Search A tiempo completoGlobal Responsibility Additional function will be to support, as needed, the clinical operation activities performed in the US (site contacts and visits of clinical trials performed in the US). Specific Responsibilities Prepare eCTD documents. Archiving of essential documents, such as Product Information with company procedure. Support and provide the...
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Regulatory Affairs Manager
hace 2 meses
Madrid, España Ergomed A tiempo completoCompany Description Ergomed PLC is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease. Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia Our company allows for employee visibility (you...
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Regulatory Affairs Manager
hace 3 días
Madrid, España Ergomed A tiempo completoCompany Description Ergomed PLC is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease. Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia Our company allows for employee visibility (you...
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Regulatory Affairs Professional
hace 2 meses
Madrid, España Parexel A tiempo completoMadrid, Spain **Job ID** R0000013557 **Category** Regulatory / Consulting **ABOUT THIS ROLE**: We are recruiting for experienced Regulatory Affairs Professionals on various levels. In this role, you will focus on clinical trial submissions. We are looking for someone who is experienced in CTA, EU-CTR knowledge and experience would be a strong plus. The...
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Regulatory Affairs Professional
hace 1 mes
Madrid, España Parexel A tiempo completoWe are recruiting for experienced Regulatory Affairs Professionals on various levels. In this role, you will focus on clinical trial submissions. We are looking for someone who is experienced in CTA, EU-CTR knowledge and experience would be a strong plus. The role can be based in our office in Madrid or remote. **Key Deliverables in the role**: - Manage...
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Clinical Operation Manager Regulatory and Start Up
hace 2 meses
Madrid, España Novasyte A tiempo completoJob Overview Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources. Essential Functions - Oversee the execution of Site Activation (including pre-award/bid defense activities)...
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Clinical Supply Chain Manager
hace 3 semanas
Madrid, España IQVIA A tiempo completoJob Overview The Clinical Supply Chain Manager is responsible for managing the strategic planning and execution of a program of assigned clinical supply chain projects. The Clinical Supply Chain Manager will support the ongoing development and optimization of the Clinical Trial Supplies department and processes. Essential Functions Interpret clinical...