Regulatory Affairs Associate
1 week ago
Dublin, Ireland - Permanent Full Time RoleXeolas Pharmaceuticals is a proudly Irish-owned specialty pharmaceutical company based in Dublin, with a team of over 70 professionals.We develop and manufacture innovative, patient-friendly pharmaceutical products for international markets.As we expand our in-house capabilities, we are seeking a skilledRegulatory Affairs Associateto support our regulatory publishing and submission activities.Role OverviewThe Regulatory Affairs Associate will play a key role in supporting the preparation, publishing, and submission of regulatory documentation for both new applications and lifecycle maintenance of existing products.This position offers an excellent opportunity to contribute to a growing regulatory function within a dynamic and innovation-driven organization.Reporting ToRegulatory Affairs ManagerKey responsibilitiesSupport the compilation of regulatory dossiers for EU and Rest of World (ROW) submissions.Assist in the preparation and submission of variations, responses to regulatory queries, and other regulatory documentation.Support with administrative tasks such as CPP, GMP and MIA request.Perform operational tasks related to document authoring, including formatting, editing, reviewing, publishing, and archiving (both paper and electronic).Conduct quality reviews of submission documents to ensure accuracy, completeness, and compliance with regulatory standards.Manage project workflows throughout the submission lifecycle, ensuring timelines are met and proactively addressing issues or resource needs.Review of R&D documents for under development projects.Stay informed of evolving regulatory requirements and submission standards.Undertake additional tasks as assigned by the Regulatory Affairs Manager.Qualifications & ExperienceBachelor's degree in Health Sciences or a related field, or equivalent relevant experience.1-3 years of experience in the pharmaceutical regulatory industry.Solid understanding of regulatory affairs principles, applicable regulations, and guidance documents.Strong attention to detail, organizational skills, and ability to manage multiple priorities.Apply for this JobPlease send a cover letter and your cv to#J-*****-Ljbffr
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Regulatory Affairs Associate
2 days ago
Dublin, Ireland Xeolas Full timeDublin, Ireland - Permanent Full Time Role Xeolas Pharmaceuticals is a proudly Irish-owned specialty pharmaceutical company based in Dublin, with a team of over 70 professionals. We develop and manufacture innovative, patient-friendly pharmaceutical products for international markets. As we expand our in-house capabilities, we are seeking a skilled...
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Associate Director Regulatory Affairs
3 weeks ago
Dublin, Ireland Quanta Consultancy Services Ltd Full timeOverviewAssociate Director Regulatory Affairs - Ireland, Dublin - 12 Month ContractAre you looking for the chance to join a life changing pharmaceutical organisation in their mission to continuously drive innovation?We are recruiting for a Associate Director Regulatory Affairs to support the Dublin function.ResponsibilitiesDeveloping and implementing global...
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Senior Associate, Regulatory Affairs
3 weeks ago
Dublin, Ireland West Pharmaceutical Services, Inc Full timePress Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Title: Senior Associate, Regulatory Affairs Requisition ID: 71039 Date: Aug 11, 2025 Location: Dublin, Leinster, IE Department: Regulatory Affairs Description: This is a hybrid position, 3 days a week onsite in...
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Dublin, Ireland Quanta Consultancy Services Ltd Full timeOverview Associate Director Regulatory Affairs - Ireland, Dublin - 12 Month Contract Are you looking for the chance to join a life changing pharmaceutical organisation in their mission to continuously drive innovation? We are recruiting for a Associate Director Regulatory Affairs to support the Dublin function. Responsibilities - Developing and...
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Senior Associate, Regulatory Affairs
1 week ago
Dublin, Ireland West Pharmaceutical Services, Inc Full timePress Tab to Move to Skip to Content LinkSelect how often (in days) to receive an alert:Select how often (in days) to receive an alert:Title: Senior Associate, Regulatory AffairsRequisition ID: *****Date: Aug 11, ****Location:Dublin, Leinster, IEDepartment: Regulatory AffairsDescription:This is a hybrid position, 3 days a week onsite in our Dublin...
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Regulatory Affairs Specialist
6 days ago
Dublin, Ireland Xeolas Full timeDublin, Ireland - Permanent Full Time RoleXeolas is an Irish-owned speciality Pharmaceutical company located in Dublin, Ireland with 80+ employees.We develop and manufacture innovative patient friendly pharmaceutical products for international markets.We are now seeking an experienced Regulatory Affairs Specialist as we expand.Overall Role ObjectiveThe...
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Director, Regulatory Affairs Cmc
2 weeks ago
Dublin, Ireland Cytokinetics Full timeCytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised.As a leader in muscle biology and the mechanics of...
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Global Regulatory Affairs Director
4 weeks ago
Dublin, Ireland Novartis Ireland Full timeGlobal Regulatory Affairs Director (Global Program Regulatory Director)Join to apply for theGlobal Regulatory Affairs Director (Global Program Regulatory Director)role atNovartis IrelandGlobal Regulatory Affairs Director (Global Program Regulatory Director)1 day ago Be among the first 25 applicantsJoin to apply for theGlobal Regulatory Affairs Director...
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Regulatory Operations Associate
4 weeks ago
Dublin, Ireland Xeolas Full timeDublin, Ireland - Permanent Full Time RoleXeolas is an Irish-owned speciality Pharmaceutical company located in Dublin, Ireland with 70+ employees.We develop and manufacture innovative patient friendly pharmaceutical products for international markets.We are now seeking an experienced Regulatory Operations Associate as we bring in-house publishing.Overall...
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Director, Regulatory Affairs Cmc
1 week ago
Dublin, Ireland Cytokinetics Full timeCytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised.As a leader in muscle biology and the mechanics of...
