Manager Labelling And Regulatory Submissions
hace 4 semanas
We are growing, grow with us Want to work in a dynamic company with daily new challenges and opportunities? Then PharmaLex is your career opportunity. PharmaLex is one of the leading service providers for the global pharmaceutical industry. We offer end-to-end regulated services and specialize in all aspects of approval and maintenance of medicinal products and medical devices. We support pharma companies throughout the entire product lifecycle, ensuring initial submissions and approvals as well as keeping compliance with pharmaceutical regulations worldwide. Our services extend way beyond market approval, providing high level strategic consultancy as well as hands-on work to extend product registrations into new markets across all regions of the world.The success of our company grows with the excellent expertise and the high motivation of our employees. If for you, your profession is not only a job but also a vocation and you enjoy working with people and in teams as part of a global organization, then you are very welcome to join usTo strengthen our successful team, we are looking for a:Manager Labelling and Regulatory SubmissionsYour Job:Participation in the preparation, revision, and compilation of informative texts for healthcare professionals and patients (SmPC, PIL, Labelling) in EU and also for non-EU markets, preferably including development of target product/labelling profiles.Manage creation and maintenance of CCDS/CCSI/RSI, as applicable, in direct collaboration with relevant departments/expert functions responsible for CCDS section content (e.G. from medical, safety department).Ensure communication to internal/external stakeholders regarding new and updated CCDSs.Escalate deviation and compliance issues to the labelling governance bodies (e.G. Safety monitoring committee, Global labelling boards) as necessary.Experience in labelling documentation and informative texts for innovator drugs on a global (headquarter) level.Ensure that regulatory affairs, development consulting and scientific affairs programs and projects are delivered to high standards.Plan and expedite the approval projects using the internally available or client-based software tools including databases and document management systems.Provide regulatory expertise to regulatory programs and projects as well as to clients.General guidance (consultancy) of PharmaLex staff and customers regarding Regulatory Submissions & Labelling activities including updates on new trends and/or changes in legislation.Present seminars and lectures on behalf of PharmaLex internally, for customers and for professional audiences.Create, revise, edit, and maintain regulatory documentation.Professional interaction with clients and Health Authorities.Coordination of project teams with internal/external staff and Regulatory Alliance Partners on a worldwide level.Participation in strategic regulatory issues.#J-18808-Ljbffr
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Manager Labelling And Regulatory Submissions
hace 4 semanas
Zaragoza, España Montezuma Winery A tiempo completoWe are growing, grow with us! Want to work in a dynamic company with daily new challenges and opportunities? Then PharmaLex is your career opportunity. PharmaLex is one of the leading service providers for the global pharmaceutical industry. We offer end-to-end regulated services and specialize in all aspects of approval and maintenance of medicinal products...
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Manager Labelling And Regulatory Submissions
hace 2 meses
Zaragoza, España Montezuma Winery Llc A tiempo completo.We are growing, grow with us!Want to work in a dynamic company with daily new challenges and opportunities? Then PharmaLex is your career opportunity.PharmaLex is one of the leading service providers for the global pharmaceutical industry. We offer end-to-end regulated services and specialize in all aspects of approval and maintenance of medicinal products...
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Regulatory Affairs Manager Labeling + Submissions
hace 5 meses
Zaragoza, España Pharmalex A tiempo completo**We are growing, grow with us!** Cencora PharmaLex is one of the leading service providers for the global pharmaceutical industry. We offer end-to-end regulated services and specialize in all aspects of approval and maintenance of medicinal products and medical devices. We support pharma companies throughout the entire product lifecycle, ensuring initial...
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Zaragoza, Zaragoza, España Montezuma Winery Llc A tiempo completoJob SummaryWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Montezuma Winery Llc. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements for labeling and submissions.Key ResponsibilitiesParticipate in the preparation and revision of labeling documents for...
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Regulatory Affairs Manager
hace 4 semanas
Zaragoza, Zaragoza, España Montezuma Winery A tiempo completoJob Title: Regulatory Affairs ManagerWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Montezuma Winery. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to maintain and improve our regulatory position.Key Responsibilities:Regulatory...
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Regulatory Affairs Manager
hace 4 semanas
Zaragoza, Zaragoza, España Montezuma Winery A tiempo completoJob Title: Regulatory Affairs ManagerWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Montezuma Winery. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to maintain and improve our regulatory position.Key Responsibilities:Regulatory...
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Regulatory Affairs Manager
hace 4 semanas
Zaragoza, Zaragoza, España Montezuma Winery Llc A tiempo completoAbout the RoleWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Montezuma Winery Llc. As a key member of our regulatory team, you will be responsible for ensuring compliance with global regulatory requirements and managing the labelling and regulatory submissions process.Key ResponsibilitiesLabelling and Regulatory Submissions:...
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Regulatory Affairs Manager
hace 4 semanas
Zaragoza, Zaragoza, España Montezuma Winery Llc A tiempo completoAbout the RoleWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Montezuma Winery Llc. As a key member of our regulatory team, you will be responsible for ensuring compliance with global regulatory requirements and managing the labelling and regulatory submissions process.Key ResponsibilitiesLabelling and Regulatory Submissions:...
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Translation Project Manager – Regulatory Submissions
hace 4 semanas
Zaragoza, España Iqvia A tiempo completoTRANSLATION PROJECT MANAGER REGULATORY SUBMISSIONSWorking with the wider Project Management team, the Translation Project Manager Regulatory Submissions is responsible for coordinating and managing the full lifecycle of Regulatory Submissions translation and localization projects to completion whilst ensuring IQVIA's standards are met.Responsibilities:Manage...
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Regulatory Submissions Coordinator
hace 1 día
Zaragoza, Zaragoza, España Medpace, Inc. A tiempo completoJob Summary:Medpace, a leading full-service clinical contract research organization, is seeking a highly skilled Regulatory Submissions Coordinator to join its Clinical Operations team in Madrid. This exciting opportunity plays a key role in the clinical trial management process, ensuring timely and compliant submissions to regulatory authorities and Ethics...
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Regulatory Submissions Coordinator
hace 1 día
Zaragoza, Zaragoza, España Medpace, Inc. A tiempo completoJob Summary:Medpace, a leading full-service clinical contract research organization, is seeking a highly skilled Regulatory Submissions Coordinator to join its Clinical Operations team in Madrid. This exciting opportunity plays a key role in the clinical trial management process, ensuring timely and compliant submissions to regulatory authorities and Ethics...
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Regulatory Submissions Coordinator
hace 2 semanas
Zaragoza, España Medpace, Inc. A tiempo completo.Job Summary:Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Submissions Coordinator to join our Clinical Operations team in Madrid. This position plays a key role in the clinical trial management process at Medpace. If you want an exciting career where you use your previous expertise...
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Regulatory Affairs Specialist |
hace 4 semanas
Zaragoza, España Zentiva Group, A.S. A tiempo completo.MissionThe Regulatory Affairs Specialist at local / country level is accountable for managing the Regulatory Affairs agenda at country level within Zentiva. This will include:Provide an efficient and proactive Regulatory service to meet the business objectives.Support proactively commercialisation of products.Ensure agility in daily interaction with...
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Regulatory Affairs Specialist
hace 4 semanas
Zaragoza, Zaragoza, España Montezuma Winery Llc A tiempo completoJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Montezuma Winery Llc. As a key member of our regulatory team, you will be responsible for ensuring compliance with global pharmaceutical regulations and managing the creation and maintenance of labelling documentation.Key ResponsibilitiesParticipate in the...
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Regulatory Affairs Specialist
hace 4 semanas
Zaragoza, Zaragoza, España Montezuma Winery Llc A tiempo completoJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Montezuma Winery Llc. As a key member of our regulatory team, you will be responsible for ensuring compliance with global pharmaceutical regulations and managing the creation and maintenance of labelling documentation.Key ResponsibilitiesParticipate in the...
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Regulatory Professional
hace 4 semanas
Zaragoza, España Alk-Abelló AS A tiempo completo.We are looking for a Regulatory ProfessionalWorld leader in allergyALK's aspiration is to become the world leader in allergy by helping as many people as possible to a better life by providing options of prevention, diagnosis, and treatment of allergy.Experience and qualifications required in the job=3 years as Regulatory Affairs Professional in a...
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Manager Regulatory Submission
hace 6 meses
Zaragoza, España Pharmalex A tiempo completo**We are growing, grow with us!** Want to work in a dynamic company with daily new challenges and opportunities? Then PharmaLex is your career opportunity. PharmaLex is one of the leading service providers for the global pharmaceutical industry. We offer end-to-end regulated services and specialize in all aspects of approval and maintenance of medicinal...
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Regulatory Administration Specialist
hace 2 semanas
Zaragoza, España Mcr International A tiempo completoLAR-2409-310REGULATORY ADMINISTRATION SPECIALISTMADRIDFrom MCR International, we are looking for a Regulatory Administration Specialist 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,...
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Regulatory Response and Investigations Lawyer
hace 4 semanas
Zaragoza, Zaragoza, España Revolut Ltd A tiempo completoAbout RevolutRevolut is a financial technology company that aims to provide a more accessible and user-friendly banking experience for its customers. With a focus on innovation and customer satisfaction, the company has grown rapidly since its inception in 2015.About the RoleThe Legal Department at Revolut plays a critical role in ensuring the company's...
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Regulatory Response and Investigations Lawyer
hace 4 semanas
Zaragoza, Zaragoza, España Revolut Ltd A tiempo completoAbout RevolutRevolut is a financial technology company that aims to provide a more accessible and user-friendly banking experience for its customers. With a focus on innovation and customer satisfaction, the company has grown rapidly since its inception in 2015.About the RoleThe Legal Department at Revolut plays a critical role in ensuring the company's...