Regulatory Affairs Specialist
6 days ago
Dublin, 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 Regulatory Affairs Specialist will report directly to the Regulatory Affairs Manager and be involved in all aspects of regulatory affairs of the company including existing licensed products as well as products under development.Reporting ToManager Regulatory AffairsRequirementsPreparation and maintenance of high quality dossiers (marketing authorisation applications/ Response to Health authority questions/ post-approval submissions).Submission of CPP/ Manufacturing authorisation requests to HPRA/MHRAReview of data intended for submission and advise regarding any deficiencies or issues.Ensure on-time submissions for all quality/ safety related changes for assigned projects.Preparation and submission of translated texts to EU/Non-EU countriesUpdate of databases and systems for all products (in-line with current SOPs)Liaise with 3rd parties (where required) to establish effective communication and relationships in order to progress regulatory activities.Liaise closely with Business Development, Product Launch, Artwork, Supply Chain and Quality colleagues to ensure alignment in all initiatives.Advise management of the status and progress of assigned projects identifying potential problems or delays, and possible solutions, as they occur and maintain a current status report for these projects.Maintain an awareness of regulatory requirements (including legislation, guidelines, industry best practice, and through liaison with competent Authorities) and use this information to optimise departmental procedures and processes and to ensure Health Authority requirements and Regulatory Compliance are maintained.Embrace Xeolas values and behaviourSupport the Xeolas business by participating in project teams to support departmental initiatives.On an ad hoc basis, carry out additional tasks on behalf of Regulatory Affairs Manager.Key Skills / Experience RequirementsFor this role, we're looking for a candidate who has an effective combination of the following qualifications, skills and experiences:Masters/ Bachelor's degree or equivalent in Science/Technology/ PharmacyMinimum 5 years of Experience in RegulatoryCapable of understanding health authority expectations for pharmaceuticals for EU/US/ROW regions.Must possess organization skills, time management skills and attention to detail.Excellent critical thinking and problem-solving abilities.Strong interpersonal and communication skillsExperience in dealing with multiple stakeholders, both internal and external.Apply for this JobPlease send a cover letter and your cv to#J-*****-Ljbffr
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Dublin, Ireland Xeolas Full timeDublin, Ireland - Permanent Full Time Role Xeolas 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 Affairs Senior Specialist as we expand. Overall Role...
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Regulatory Affairs Associate
1 week ago
Dublin, Ireland Xeolas Full timeDublin, 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...
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Regulatory Affairs Associate
1 day 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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Senior Specialist, Regulatory Affairs
1 week ago
Dublin, Ireland West Pharmaceutical Services, Inc Full timeOverviewTitle: Senior Specialist, Regulatory AffairsRequisition ID: *****Date: Sep 3, ****Location: Dublin, Leinster, IEDepartment: Regulatory AffairsDescription:At West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century.Our story began when Herman O. West solved...
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Dublin, Ireland West Pharmaceutical Services, Inc Full timeOverview Title: Senior Specialist, Regulatory Affairs Requisition ID: 71195 Date: Sep 3, 2025 Location: Dublin, Leinster, IE Department: Regulatory Affairs Description: At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when...
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Dublin Pike, Ireland West Pharmaceutical Services Full timeSenior Specialist, Regulatory Affairs Requisition ID:71195 Date:Sep 3, 2025 Location: Dublin, Leinster, IE Department:Regulatory Affairs Description: This is a hybrid position, 3 days a week onsite in our Dublin location. At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for...
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Senior Director of Regulatory Affairs
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Dublin Pike, Ireland Panda International Full timeOverview Director / Senior Director, Regulatory Affairs – Europe Location: Ireland (onsite presence required, hybrid flexibility) Therapeutic Area: Rare Diseases We are supporting a fast-growing biopharmaceutical company developing transformative therapies for rare diseases . With an established global operations and expanding European presence, the...
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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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Head of Regulatory Affairs, Europe
7 days ago
Dublin, Ireland Scholar Rock Full timeOverview Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins, the clinical-stage company is focused on advancing innovative treatments...
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Head Of Regulatory Affairs, Europe
6 days ago
Dublin, Ireland Scholar Rock Full timeOverviewScholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need.As a global leader in the biology of the transforming growth factor beta (TGFß) superfamily of cell proteins, the clinical-stage company is focused on advancing innovative treatments...
