EU Regulatory Affairs Specialist
4 days ago
The Regulatory Compliance Specialist will be responsible for ensuring that all medical products meet regulatory requirements. This includes maintaining product registrations, acting as EUAR and UKRP, and managing post-market actions.
Key Responsibilities- Maintain product registrations in all territories.
- Act as EUAR and UKRP for partners.
- Manage post-market actions and NCA communications.
- Provide advice on new legislation and business needs.
- Educated to degree level or equivalent.
- Interest in gaining a Regulatory Affairs Certificate (RAC) in medical devices.
- Good written and verbal communication skills.
- Quality Management and inspection/auditing experience.
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Regulatory Affairs Specialist
3 days ago
Dublin, Dublin City, Ireland Cpl Full timeJob Title: Regulatory Affairs SpecialistAbout the Role:We are seeking a highly skilled Regulatory Affairs Specialist to join our team in Dublin. As a Regulatory Affairs Specialist, you will be responsible for managing EU marketing authorisation dossiers and submissions, preparing and filing EU submissions, and writing local modules and administrative...
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Regulatory Affairs Specialist
2 days ago
Dublin, Dublin City, Ireland CPL Full timeThornshaw Scientific, a division of the CPL Group, is seeking an experienced Regulatory Affairs Specialist to join our Dublin team. As a key member of our regulatory affairs team, you will be responsible for managing EU marketing authorisation dossiers and submissions, preparing and filing EU submissions, and writing local modules and administrative...
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Regulatory Affairs Specialist
4 days ago
Dublin, Dublin City, Ireland Cpl Healthcare Full timeThornshaw Scientific, in collaboration with a global pharmaceutical company, is seeking an experienced Regulatory Affairs Specialist to join the Dublin team.The role presents an opportunity for individuals with a strong background in EU regulatory affairs to contribute to the development and maintenance of marketing authorisation dossiers and submissions.Key...
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Regulatory Affairs Specialist
14 hours ago
Dublin, Dublin City, Ireland Cpl Healthcare Full timeCpl Healthcare has partnered with a global pharmaceutical company to recruit a Regulatory Affairs Specialist for their Dublin team.Key Responsibilities:Manage EU marketing authorisation dossiers and submissions, including lifecycle activities, variations, transfers, and renewals.Prepare and file EU submissions, including life-cycle maintenance variations,...
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Director, Regulatory Affairs EU
3 weeks ago
Dublin, Dublin City, Ireland Emergent Biosolutions Full timeThose who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. JOB SUMMARY The Director,...
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Regulatory Affairs Senior Specialist
8 hours ago
Dublin, Dublin City, 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 Affairs Senior Specialist as we expand.Overall Role...
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Director, Regulatory Affairs EU
2 weeks ago
Dublin, Dublin City, Ireland Emergent BioSolutions Full timeSelect how often (in days) to receive an alert:Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products...
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Director, Regulatory Affairs EU
4 weeks ago
Dublin, Dublin City, Ireland Emergent BioSolutions Full timeSelect how often (in days) to receive an alert:Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products...
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Director, Regulatory Affairs EU
3 weeks ago
Dublin, Dublin City, Ireland Emergent BioSolutions Full timeSelect how often (in days) to receive an alert:Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products...
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Director, Regulatory Affairs EU
2 weeks ago
Dublin, Dublin City, Ireland Emergent BioSolutions Full timeSelect how often (in days) to receive an alert:Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products...
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Regulatory Affairs Senior Specialist
2 weeks ago
Dublin, Dublin City, 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 Affairs Senior Specialist as we expand.Overall Role...
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Regulatory Affairs Specialist
4 days ago
Dublin, Dublin City, Ireland Cpl Healthcare Full timeThornshaw Scientific, a global pharmaceutical company, is collaborating with Cpl Healthcare to recruit a Regulatory Affairs Officer for their Dublin team. This role involves managing EU marketing authorisation dossiers and submissions, preparing and filing EU submissions, and communicating effectively with European Regulatory Authorities.Key...
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Regulatory Affairs Specialist
2 days ago
Dublin, Dublin City, Ireland CPL Full timeJob DescriptionThornshaw Scientific, a division of CPL Group, is collaborating with a global pharmaceutical company to fill the role of Regulatory Affairs Officer in our Dublin team. This position involves managing EU marketing authorisation dossiers and submissions for current pharmaceutical products. The ideal candidate will have life science...
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Senior Regulatory Affairs Specialist
2 weeks ago
Dublin, Dublin City, Ireland Life Science Recruitment Full timeSenior Regulatory Affairs SpecialistOur client a high potential medical device start up current seeks a Senior Regulatroy Affairs Specialist to join their team. Reporting to the Director of Quality and Regulatory Affairs the Senior Regulatory Affairs will take an active role in developing the Regulatory strategy in Europe and the US and interacting with the...
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Regulatory Affairs Specialist
2 days ago
Dublin, Dublin City, Ireland Novartis Farmacéutica Full timeJob SummaryWe are seeking a talented Regulatory Affairs Specialist to join our team as a key member of our Central Integrated Scientific Review Committee Lead function. The successful candidate will have a strong background in regulatory affairs, with experience in managing the review process for clinical documents across therapeutic areas in Development.As...
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Regulatory Affairs Specialist
6 days ago
Dublin, Dublin City, Ireland Robert Walters Ireland Full timeA leading Fintech Company in Dublin is seeking an experienced Regulatory Affairs Specialist to join their team.This role involves ensuring the company's compliance with regulatory standards and managing relations with the Central Bank of Ireland (CBI).The successful candidate will be responsible for developing the compliance strategy, aligning it with...
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EU Regulatory Coordinator
3 days ago
Dublin, Dublin City, Ireland Cpl Full timeRegulatory Affairs Officer Job Summary:We are seeking a highly skilled Regulatory Affairs Officer to join our team in Dublin. The successful candidate will be responsible for managing EU marketing authorisation dossiers and submissions, preparing and filing EU submissions, and writing local modules and administrative documents.Key Accountabilities:Manage EU...
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Regulatory Affairs Specialist
3 days ago
Dublin, Dublin City, Ireland TN Ireland Full timeJob DescriptionCompany OverviewTN Ireland is a leading provider of innovative solutions in the medical device industry.Job SummaryWe are seeking a highly skilled and experienced Regulatory Affairs Specialist to join our team.Key ResponsibilitiesAct as Regulatory Affairs lead for new product development projects, providing solution-based advice to development...
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Dublin, Dublin City, Ireland Vectura Group Full timeJob SummaryWe are seeking an experienced Regulatory Affairs Specialist to contribute to our regulatory activities, ensuring the successful and timely approval of relevant medical device submissions.This role will ensure global regulatory compliance while supporting Vectura's corporate goals. The successful candidate will provide strategic regulatory guidance...
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Regulatory Affairs Professional
7 days ago
Dublin, Dublin City, Ireland CPL Full timeAt Thornshaw Scientific, our collaboration with a leading global pharmaceutical company has led to an exciting opportunity for a skilled Regulatory Affairs Officer to join our Dublin team.About the RoleThe successful candidate will be responsible for managing EU marketing authorisation dossiers and submissions, including lifecycle activities, variations,...