Manager Labelling And Regulatory Submissions
hace 2 meses
.We are growing, grow with usWant 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 lookingfor a:Manager Labelling and Regulatory SubmissionsYour JobParticipation in the preparation and revision and compilation of the 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 profilesManages 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)Ensures communication to internal / external stakeholders regarding new and updated CCDSsEscalates deviation and compliance issues to the labelling governance bodies (e.G. Safety monitoring committee, Global labelling boards) as necessaryExperience in labelling documentation and informative texts for innovator drugs on a global (headquarter) levelEnsuring that regulatory affairs, development consulting and scientific affairs programs and projects are delivered to high standardsPlanning and expediting the approval projects using the internally available or client-based software tools including databases and document management systemsProviding regulatory expertise to regulatory programs and projects as well as to clientsGeneral guidance (consultancy) of PharmaLex staff and customers regarding Regulatory Submissions & Labelling activities including also updates on new trends and/or changes in legislationPresenting seminars and lectures on behalf of PharmaLex internally, for customers and for professional audiencesCreation, revision, editing and maintenance of regulatory documentationProfessional interaction with clients and Health AuthoritiesCoordination of project teams with internal / external staff and Regulatory Alliance Partners on a world-wide levelParticipation in strategic regulatory issues incl
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Manager Labelling And Regulatory Submissions
hace 1 mes
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 1 mes
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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Regulatory Affairs Manager Labeling + Submissions
hace 6 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, 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 2 semanas
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, 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 4 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 1 mes
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 Manager
hace 1 semana
Zaragoza, Zaragoza, España Montezuma Winery Llc A tiempo completoRegulatory Affairs ManagerWe 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 pharmaceutical regulations and managing the creation and maintenance of labelling documentation.Key Responsibilities:Participate in...
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Regulatory Affairs Specialist
hace 5 días
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 Manager
hace 1 semana
Zaragoza, Zaragoza, España Montezuma Winery Llc A tiempo completoJob SummaryWe are seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our regulatory team, you will be responsible for managing the preparation and revision of labeling and regulatory submissions for our pharmaceutical products.Key Responsibilities:Manage the creation and maintenance of labeling and regulatory...
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Regulatory Affairs Manager CMC
hace 1 semana
Zaragoza, Zaragoza, España Mabxience A tiempo completoJob SummaryThe Junior Manager, Regulatory Affairs CMC is responsible for providing regulatory technical assistance to development teams and ensuring the adequacy of CMC documentation for global regulatory submissions. This includes specific requirements for regional registration processes. The position supports and promotes all regulatory CMC tasks...
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Regulatory Affairs Manager CMC
hace 5 días
Zaragoza, Zaragoza, España Mabxience A tiempo completoJob Summary:The Junior Manager, Regulatory Affairs CMC is responsible for providing regulatory relevant technical assistance to development teams and ensuring the adequacy of CMC documentation for global regulatory submissions, including specific requirements for regional registration processes. This position supports and promotes all regulatory CMC tasks...
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Junior Manager Regulatory Affairs Cmc
hace 1 semana
Zaragoza, España Mabxience A tiempo completo.Overview:The Junior Manager, Regulatory Affairs CMC is responsible to provide regulatory relevant technical assistance to development teams and ensures adequacy of CMC documentation for global regulatory submissions including specific requirements for regional registration processes.The position supports and promotes all regulatory CMC tasks throughout the...
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Regulatory Affairs Specialist
hace 5 días
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. This is a challenging opportunity for a professional with experience in labeling activities for innovator drugs on a global level.Key ResponsibilitiesParticipate in the preparation and revision of informative texts for healthcare professionals...
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Senior Regulatory Affairs Manager
hace 8 horas
Zaragoza, Zaragoza, España Cpl Healthcare A tiempo completoJob Title:Senior Regulatory Affairs Manager - Medical Device/Post-Job Summary:Cpl Healthcare is seeking a Senior Regulatory Affairs Manager to join our team in Spain, Madrid. As a Senior Regulatory Affairs Manager, you will be responsible for the strategic lifecycle management of our medical device portfolio, including post-CE approval and operational...
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Regulatory Professional
hace 1 mes
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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Regulatory Affairs Director
hace 5 días
Zaragoza, Zaragoza, España Cpl Healthcare A tiempo completoJob Title: Associate Director, Regulatory Affairs Medical Devices Lifecycle ManagementJob Type: Full Time, Permanent PositionLocations: Spain, Madrid – HybridRemuneration: Attractive salary and packageCpl Healthcare is seeking an experienced Associate Director, Regulatory Affairs Medical Devices Lifecycle Management to join our team. As a key member of our...
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Regulatory And Start Up Specialistnew
hace 2 semanas
Zaragoza, España Precision Medicine Group A tiempo completo.Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific...
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Regulatory Affairs Director
hace 1 semana
Zaragoza, Zaragoza, España Cpl Healthcare A tiempo completoJob Title: Associate Director, Regulatory Affairs - Medical Device/Post-Market SurveillanceJob Type: Full Time, Permanent PositionLocations: Spain, Madrid – HybridRemuneration: Attractive salary and packageAn exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology and Hepatology. Due to...
