1 job found in budapest, budapest

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    • budapest, budapest
    • permanent
    Pozíció leírása / Job descriptionSupport the regulatory submission creation and the registration tracking of the company, the regulatory submission targets from a regulatory operational perspective for the whole region.Review and manage the complexity of planning, managing, tracking, assembling and delivering of regulatory content, to meet regulatory strategy, regulatory compliance and informational needs of regional regulatory authority.Help with project management tasks, including managing dynamic timelines, interacting and negotiating and collaborating with global stakeholdersYour main functions would be:Managing operational aspects of submission planning for assigned productssubmission planningdocument retrievalsubmission creation and delivery to Health AuthoritiesElvárások / RequirementsBachelors degree in a Life Science related discipline.High level expertise and knowledge of the regulatory landscape, its registration procedures and a thorough understanding of the technical requirements for dossiers (e.g. eCTD and other submission formats).Affinity to work with complex IT systemsEnglish language knowledge, intermediate or aboveAt least 2 years experience in the regulatory operations area, regulatory affairs will be an asset.Amit kínálunk / OfferA career path that will allow you to become a Subject Matter ExpertThe opportunity to work on different Regulatory processes across different projectsTrainings on various competencies and skillsLanguage courses and trainingOn-site relax & gym roomsVolunteering, sport and employee eventsKapcsolattartó / InformationDo you have any questions? If so, please contact me via eszter.csigo-tolnai@randstad.hu
    Pozíció leírása / Job descriptionSupport the regulatory submission creation and the registration tracking of the company, the regulatory submission targets from a regulatory operational perspective for the whole region.Review and manage the complexity of planning, managing, tracking, assembling and delivering of regulatory content, to meet regulatory strategy, regulatory compliance and informational needs of regional regulatory authority.Help with project management tasks, including managing dynamic timelines, interacting and negotiating and collaborating with global stakeholdersYour main functions would be:Managing operational aspects of submission planning for assigned productssubmission planningdocument retrievalsubmission creation and delivery to Health AuthoritiesElvárások / RequirementsBachelors degree in a Life Science related discipline.High level expertise and knowledge of the regulatory landscape, its registration procedures and a thorough understanding of the technical requirements for dossiers (e.g. eCTD and other submission formats).Affinity to work with complex IT systemsEnglish language knowledge, intermediate or aboveAt least 2 years experience in the regulatory operations area, regulatory affairs will be an asset.Amit kínálunk / OfferA career path that will allow you to become a Subject Matter ExpertThe opportunity to work on different Regulatory processes across different projectsTrainings on various competencies and skillsLanguage courses and trainingOn-site relax & gym roomsVolunteering, sport and employee eventsKapcsolattartó / InformationDo you have any questions? If so, please contact me via eszter.csigo-tolnai@randstad.hu

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