Regulatory Professional
hace 4 semanas
.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 pharmaceutical company, preferably multinational.Experience in international projects will be an asset.Bachelor of Science / Master of Science in the Health Science field (e.G. Pharmacy, Biology, etc.).Master's Degree in the Pharmaceutical Industry is strongly recommended.Specific regulatory affairs courses strongly recommended.ResponsibilitiesHandling regulatory CMC documentation of the products manufactured at site Madrid, for world-wide submissions (MAA, Variations, Renewals).Maintenance activities (CMC variations) for the products manufactured at site Madrid and registered world-wide.Local regulatory activities for the products registered in Spain.Handling product information (SmPCs, leaflets, labels).Regulatory surveillance & regulatory support to other functional areas.Member of cross-functional / cross-site projects.Important tasks to be handled in the job:Coordination, preparation & submission of CMC documentation (CTD Modules 2.3 & 3) for Marketing Authorisation Applications / Variations / Renewals of products manufactured at site Madrid, in compliance with local or regional requirements, including input to the regulatory strategies & responses to questions from regulatory authorities during assessment.Coordination, preparation & submission of CMC documentation for post-approval regulatory commitments.Handling the national phase of variations/MAA submitted by European procedures (MRP/DCP) for products manufactured at other ALK sites - including fee payment, translation to local language of product information (SmPC, PL, Labelling), change requests for printed packaging materials – and follow-up with AEMPS until approval.Preparation & submission of documentation on products manufactured at site Madrid, to obtain special licences/import licenses in other countries.Reviewing change control requests, including assessment of regulatory impact, defining variation classification/documentation needed and submitting the corresponding variation applications.Writing/adapting to local requirements SmPCs, PL, labels & abridged SmPCs for promotional materials.Applying for Certificates of Pharmaceutical Products (CPP) / Free Sale Certificates / other & handling or coordinating the subsequent legalization process.Handling local activities for the products registered in Spain, e.G. product launch notifications & applications for yearly maintenance of the products via AEMPS portal.Providing regulatory input to the Annual Product Quality Review (APQR)
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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 Solicitor
hace 1 día
Zaragoza, Zaragoza, España Dac Beachcroft Llp A tiempo completoJob Title: Regulatory SolicitorWe are seeking a highly skilled Regulatory Solicitor to join our team at Dac Beachcroft Llp. As a Regulatory Solicitor, you will be responsible for providing expert advice and representation to clients in relation to regulatory matters.About the Role:Provide expert advice and representation to clients in relation to regulatory...
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Regulatory Solicitor
hace 1 día
Zaragoza, Zaragoza, España Dac Beachcroft Llp A tiempo completoJob Title: Regulatory SolicitorWe are seeking a highly skilled Regulatory Solicitor to join our team at Dac Beachcroft Llp. As a Regulatory Solicitor, you will be responsible for providing expert advice and representation to clients in relation to regulatory matters.About the Role:Provide expert advice and representation to clients in relation to regulatory...
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Regulatory Compliance Specialist
hace 1 día
Zaragoza, Zaragoza, España Mcr International A tiempo completoRegulatory Administration SpecialistMcr International is seeking a highly skilled Regulatory Administration Specialist to join our team. As a key member of our regulatory team, you will play a crucial role in supporting the implementation of our regulatory strategy to grow and maintain our portfolio in the South Cluster.Key Responsibilities:Ensure timely...
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Regulatory Compliance Specialist
hace 1 día
Zaragoza, Zaragoza, España Mcr International A tiempo completoRegulatory Administration SpecialistMcr International is seeking a highly skilled Regulatory Administration Specialist to join our team. As a key member of our regulatory team, you will play a crucial role in supporting the implementation of our regulatory strategy to grow and maintain our portfolio in the South Cluster.Key Responsibilities:Ensure timely...
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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 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 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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Head of Corporate and Regulatory Affairs
hace 1 día
Zaragoza, Zaragoza, España British American Tobacco A tiempo completoHead of Corporate and Regulatory AffairsBritish American Tobacco is seeking a seasoned professional to lead our corporate and regulatory affairs efforts in Iberia. As a key member of our team, you will develop and implement strategies to ensure the company's regulatory approach is aligned with our business objectives.Key Responsibilities:Develop and execute...
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Head of Corporate and Regulatory Affairs
hace 1 día
Zaragoza, Zaragoza, España British American Tobacco A tiempo completoHead of Corporate and Regulatory AffairsBritish American Tobacco is seeking a seasoned professional to lead our corporate and regulatory affairs efforts in Iberia. As a key member of our team, you will develop and implement strategies to ensure the company's regulatory approach is aligned with our business objectives.Key Responsibilities:Develop and execute...
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Translator (Regulatory) Baltics Languages
hace 4 semanas
Zaragoza, España Iqvia Llc A tiempo completoTranslator (Regulatory) BALTICS LANGUAGESApply to join us at our Madrid Center of Excellence office! This position will provide broad support on monitoring and analyzing the changes and evolution of the local regulatory environment, including guidance and regulations from regulatory authorities, trade organizations, working groups, and relevant industry...
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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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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 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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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...
