Manager Labelling And Regulatory Submissions
hace 3 semanas
.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 Job- Participation 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 profiles- Manages 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 CCDSs- Escalates 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- Ensuring that regulatory affairs, development consulting and scientific affairs programs and projects are delivered to high standards- Planning and expediting the approval projects using the internally available or client-based software tools including databases and document management systems- Providing 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 also updates on new trends and/or changes in legislation- Presenting seminars and lectures on behalf of PharmaLex internally, for customers and for professional audiences- Creation, revision, editing and maintenance of regulatory documentation- Professional interaction with clients and Health Authorities- Coordination of project teams with internal / external staff and Regulatory Alliance Partners on a world-wide level- Participation in strategic regulatory issues incl
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Regulatory Affairs Manager Labeling + Submissions
hace 4 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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Zaragoza, España Lilly A tiempo completo..Job Description: We're looking for people who are determined to make life better for people around the world. Purpose: The Senior Director/Executive Director, Global Regulatory Affairs (GRA)-EMEA or Regional Regulatory Scientist is accountable to establish the local regulatory strategy and plan for assigned product(s) in region/country, ensure local plan...
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Manager Regulatory Submission
hace 5 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 Compliance Manager
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Zaragoza, España American Express A tiempo completo.You Lead the Way. We've Got Your Back. With the right backing, people and businesses have the power to progress in incredible ways. When you join Team Amex, you become part of a global and diverse community of colleagues with an unwavering commitment to back our customers, communities and each other. Here, you'll learn and grow as we help you create a...
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Senior Permitting and Regulatory Specialist
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Zaragoza, Zaragoza, España Blue Power Partners A tiempo completoAbout Blue Power PartnersWe are a global consultancy and project development company with a dedicated focus on developing renewable energy. Our team is expanding in Spain, and we are seeking a talented colleague to join us in Zaragoza.About the RoleYou will be responsible for providing support to ongoing and new development projects focused on permitting and...
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Senior Permitting and Regulatory Specialist
hace 4 días
Zaragoza, Zaragoza, España Blue Power Partners A tiempo completoAbout Blue Power PartnersWe are a global consultancy and project development company with a dedicated focus on developing renewable energy. Our team is expanding in Spain, and we are seeking a talented colleague to join us in Zaragoza.About the RoleYou will be responsible for providing support to ongoing and new development projects focused on permitting and...
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Legal Counsel
hace 2 meses
Zaragoza, España Revolut A tiempo completoLegal Counsel (Regulatory Response and Investigations) About Revolut People deserve more from their money. More visibility, more control, more freedom. Since 2015, Revolut has been on a mission to deliver just that. With an arsenal of awesome products that span spending, saving, travel, transfers, investing, exchanging, and more, we've helped 40+ million...
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Legal Counsel
hace 2 meses
Zaragoza, España Revolut A tiempo completoLegal Counsel (Regulatory Response and Investigations)About RevolutPeople deserve more from their money. More visibility, more control, more freedom. Since 2015, Revolut has been on a mission to deliver just that. With an arsenal of awesome products that span spending, saving, travel, transfers, investing, exchanging, and more, we've helped 40+ million...
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Legal Counsel
hace 2 meses
Zaragoza, España Revolut A tiempo completoLegal Counsel (Regulatory Response and Investigations)About RevolutPeople deserve more from their money. More visibility, more control, more freedom. Since 2015, Revolut has been on a mission to deliver just that. With an arsenal of awesome products that span spending, saving, travel, transfers, investing, exchanging, and more, we've helped 40+ million...
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Senior Permitting and Regulatory Specialist
hace 2 días
Zaragoza, Zaragoza, España Blue Power Partners AS A tiempo completoAbout Blue Power Partners A/SWe are a global consultancy and project development company with a dedicated focus on developing renewable energy. Our team is expanding in Spain, and we are seeking a talented colleague to join our Onshore Development Team in Zaragoza.About the RoleYou will be responsible for providing support to ongoing and new development...
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Senior Permitting and Regulatory Specialist
hace 1 día
Zaragoza, Zaragoza, España Blue Power Partners AS A tiempo completoAbout Blue Power Partners A/SWe are a global consultancy and project development company with a dedicated focus on developing renewable energy. Our team is expanding in Spain, and we are seeking a talented colleague to join our Onshore Development Team in Zaragoza.About the RoleYou will be responsible for providing support to ongoing and new development...
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Puc980 | Competition
hace 3 días
Zaragoza, España Jr Spain A tiempo completoJob Description:Ryanair Holdings plc, Europe's largest airline group, is the parent company of Buzz, Lauda, Malta Air, Ryanair & Ryanair UK. Carrying 165m guests p.A. on more than 2,500 daily flights from 89 bases, the Group connects almost 230 destinations in 36 countries on a fleet of over 500 aircraft, with a further 145 Boeing 737s on order, which will...
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Head of Conflicts and Interest Management
hace 3 días
Zaragoza, Zaragoza, España Reconocida empresa A tiempo completoAbout the role: This position may be based in a global hub and reports to the Chief Compliance Officer.Key Responsibilities:Team Leadership: Oversee a team of compliance professionals administering the conflicts management system, including policies and procedures focused on personal securities trading, gifts & entertainment, restricted securities list...
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Head of Conflicts and Interest Management
hace 5 días
Zaragoza, Zaragoza, España Reconocida empresa A tiempo completoAbout the role: This position may be based in a global hub and reports to the Chief Compliance Officer.Key Responsibilities:Team Leadership: Oversee a team of compliance professionals administering the conflicts management system, including policies and procedures focused on personal securities trading, gifts & entertainment, restricted securities list...
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Vb358 | Head Of Conflicts And Interest, Global Controls
hace 2 semanas
Zaragoza, España Reconocida Empresa A tiempo completoAbout the role: This position may be based in Madrid, Amsterdam, or Frankfurt, and reports to the Global Chief Compliance Officer - Global Controls.Job responsibilities: The Head of Conflicts of Interest will be responsible for developing strategies and managing a program dedicated to identifying and managing conflicts of interest at Morningstar. Specific...
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Zaragoza, España Reconocida Empresa A tiempo completo.About the role: This position may be based in Madrid, Amsterdam, or Frankfurt, and reports to the Global Chief Compliance Officer - Global Controls.Job responsibilities: The Head of Conflicts of Interest will be responsible for developing strategies and managing a program dedicated to identifying and managing conflicts of interest at Morningstar. Specific...
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D152 | Global Regulatory Affairs Lead
hace 4 semanas
Zaragoza, España Sobi Group A tiempo completoStatistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!At Sobi, each person brings their unique talents to work as a team and make a difference....
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Zaragoza, España Reconocida Empresa A tiempo completoAbout the role: This position may be based in Madrid, Amsterdam, or Frankfurt, and reports to the Global Chief Compliance Officer - Global Controls.Job responsibilities:Team Leadership: Overseeing a team of compliance professionals currently based in Toronto, Europe, and Mumbai which administers the Morningstar conflicts management system, including policies...
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Health and Safety Manager
hace 3 días
Zaragoza, Zaragoza, España Antal International A tiempo completo**Job Summary**As a Health and Safety Manager for Europe and Middle East at Antal International, you will be responsible for developing, implementing, maintaining, and overseeing health and safety programs and initiatives across retail stores, ensuring awareness and compliance with all regulatory requirements. You will promote a culture of safety awareness...