Regulatory Affairs Specialist
4 weeks 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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(10/19/2025 A) Regulatory Affairs Specialist
3 weeks ago
Dublin, Ireland Xeolas Full timeDublin, Ireland - Permanent Full Time Role Xeolas 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...
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Regulatory Affairs Associate
3 weeks 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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Head of Regulatory Affairs, Europe
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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
4 weeks 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...
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Regulatory Affairs Analyst
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Regulatory Affairs Analyst
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Dublin, Ireland GoFundMe Full timeOverview GoFundMe is hiring a Regulatory Affairs Analyst to interpret regulatory changes and ensure our products, policies, and communications comply with all relevant laws and standards. This includes preparing reports, documentation, and responses to regulatory agencies while collaborating across teams to integrate compliance into product planning. Join...
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Sr Mgr Regulatory Affairs
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Senior Director, Regulatory Affairs
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Dublin, Ireland Perrigouk Full timeSelect how often (in days) to receive an alert: Senior Director, Regulatory Affairs - CMC, Regulatory Operations & Lifecycle Management Location: London, GB, SW11 7BW Chatillon Cedex, FR, 92320 Ghent, BE, 9050 Dublin, IE, D02 TY74 At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All....
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Dublin, Ireland Gilead Sciences, Inc. Full timeAt Gilead, we're creating a healthier world for all people.For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe.We continue to fight against the world's biggest health challenges, and our...
