Regulatory Affairs Specialist
6 days ago
Eli Lilly And Company is a global healthcare leader committed to making life better for people around the world. We are headquartered in Indianapolis, Indiana, and our team of over 2000 employees across 60 nationalities delivers innovative solutions across various business service functions.
We offer a premium workspace on our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Our holistic benefits enhance the career experience for our colleagues, including in-house People Development services, Educational Assistance, and 'Live Your BEST Life' wellbeing initiatives.
We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network.
The Cork CMC Regulatory Scientist will lead the various aspects of global marketing authorization submission management processes in partnership with the GRA-CMC Regulatory Scientist. This involves managing submission content for Drug Substance and Drug Product, providing guidance on structure and content placement within CTD registration submissions, and assisting with submission related Ministry of Health responses or Lilly affiliate questions.
Responsibilities include providing regulatory support for existing Drug Substances and Drug Products by preparing and maintaining the appropriate regulatory submission documentation needed to obtain & maintain marketing authorizations. The successful candidate will also partner with GRA-CMC Regulatory Scientists to manage outsourcing activities & contract manufacturers.
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Regulatory Affairs Specialist
4 days ago
Cork, Cork, Ireland Pale Blue Dot®Recruitment Limited Full timeJob DescriptionPale Blue Dot Recruitment Limited is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Medical Devices division, you will play a critical role in ensuring compliance with regulatory requirements for medical devices.The ideal candidate will have a strong background in regulatory affairs, with...
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Regulatory Affairs Specialist
5 days ago
Cork, Cork, Ireland Eli Lilly And Company Full timeJob OverviewEli Lilly and Company is a global healthcare leader dedicated to making life better for people around the world. We are committed to discovering and bringing life-changing medicines to those who need them, improving the understanding and management of disease, and giving back to our communities through philanthropy and volunteerism.We are seeking...
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Regulatory Affairs Specialist
10 hours ago
Cork, Cork, Ireland Life Science Recruitment Full timeRegulatory Affairs Specialist (Remote/Hybrid)Our client, a high potential start-up medical device company, currently seeks a Regulatory Affairs Specialist to join their team. Reporting to the Clinical and Regulatory Affairs Manager, the Regulatory Specialist will be responsible for helping with compliance to standards, regulatory submissions, and annual...
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Regulatory Affairs Specialist
2 weeks ago
Cork, Cork, Ireland Life Science Recruitment Full timeRegulatory Affairs Specialist (Remote/Hybrid)Our client, a high potential start-up medical device company, currently seeks a Regulatory Affairs Specialist to join their team. Reporting to the Clinical and Regulatory Affairs Manager, the Regulatory Specialist will be responsible for helping with compliance to standards, regulatory submissions, and annual...
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Senior Regulatory Affairs Specialist
6 days ago
Cork, Cork, Ireland Life Science Recruitment Ltd Full timeLife Science Recruitment Ltd is seeking a Senior Regulatory Affairs Specialist to develop and execute the regulatory strategy for the US and Canadian market.This role involves developing, updating, and executing US and Canada registration strategy. The ideal candidate will assist or lead in the development of regulatory strategy by leveraging scientific,...
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Senior Regulatory Affairs Specialist
4 days ago
Cork, Cork, Ireland Pale Blue Dot Recruitment Full timeSocial network you want to login/join with:Senior Regulatory Affairs Specialist, ClareLocation:Job Category:Biotech/PharmaEU work permit required:YesJob Reference:kttmeodyJob Views:1Posted:24.03.2025Expiry Date:08.05.2025Job Description:Our Client, a leading Medical Device company based in Clare, is seeking a Senior Regulatory Affairs Specialist to join...
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Senior Regulatory Affairs Specialist
2 days ago
Cork, Cork, Ireland Life Science Recruitment Ltd Full timeJob SummaryThe Senior Regulatory Affairs Specialist will develop and execute the regulatory strategy for the US and Canadian market. As a key member of the team, you will work closely with cross-functional partners to deliver integrated regulatory strategies that meet business objectives.Main ResponsibilitiesDevelop, update, and execute US and Canada...
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Senior Regulatory Affairs Specialist
4 days ago
Cork, Cork, Ireland Pale Blue Dot®Recruitment Limited Full timeOur Client, A leading Medical Device company based in Clare, are seeking a Senior Regulatory Affairs Specialist to join their team. This position will be responsible for developing and implementing regulatory strategies to support the timely and successful registration, approval, and maintenance of company and client products.Responsibilities include but are...
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Senior Regulatory Affairs Specialist
4 days ago
Cork, Cork, Ireland Pale Blue Dot®Recruitment Limited Full timeDirect message the job poster from Pale Blue Dot Recruitment LimitedPale Blue Dot Recruitment | The Experts in MedTech RecruitmentOur Client, a leading Medical Device company based in Clare, is seeking a Senior Regulatory Affairs Specialist to join their team. This position will be responsible for developing and implementing regulatory strategies to support...
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Senior Regulatory Affairs Specialist
19 hours ago
Cork, Cork, Ireland HERO Recruitment Full timeGlobal Regulatory Affairs - PrincipalOur client seeks a Regulatory Affairs professional to join their employees around the world who work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.The role will be within the...
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Regulatory Affairs Manager
6 days ago
Cork, Cork, Ireland Eli Lilly and Company Full timeAt Eli Lilly and Company, we are dedicated to discovering and delivering life-changing medicines that improve the lives of people around the world. Our team is comprised of talented individuals who share a passion for innovation and excellence in regulatory affairs. We are seeking a highly skilled Regulatory Affairs Manager to join our team and contribute to...
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Regulatory Affairs Specialist
6 days ago
Cork, Cork, Ireland Hobson Prior Full timeJob DescriptionHobson Prior is seeking a Lead Scientist for Global Regulatory Affairs in Chemistry, Manufacturing and Controls. This role focuses on providing strategic and operational guidance for the development of Chemistry, Manufacturing and Controls processes. You will be involved in supporting worldwide clinical trials, market registration submissions,...
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Medical Device Regulatory Affairs Manager
3 days ago
Cork, Cork, Ireland Pale Blue Dot®Recruitment Limited Full timeAbout the RoleWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our client's team in Clare. As a key member of the regulatory affairs department, you will be responsible for developing and implementing regulatory strategies to support the timely and successful registration, approval, and maintenance of company and client...
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Regulatory Affairs Quality Manager
3 days ago
Cork, Cork, Ireland Stryker Group Full timeJob OverviewThe Quality Management Systems Specialist will play a pivotal role in shaping the future of our quality management system. As a member of our QMS team, you will be responsible for driving quality excellence, ensuring regulatory compliance, and supporting business growth.Key Responsibilities:Develop and maintain a deep understanding of our quality...
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Regulatory Affairs Expert
3 days ago
Cork, Cork, Ireland Pale Blue Dot®Recruitment Limited Full timeAbout the CompanyPale Blue Dot Recruitment Limited is a recruitment agency specializing in the placement of professionals in the MedTech industry.Job Overview:We are seeking a talented Senior Regulatory Affairs Specialist to support the growth and expansion of our client's business. The ideal candidate will have a strong background in regulatory affairs,...
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Senior Regulatory Affairs Professional
3 days ago
Cork, Cork, Ireland Pale Blue Dot®Recruitment Limited Full timeAbout this OpportunityPale Blue Dot Recruitment Limited is pleased to offer a challenging and rewarding position as a Senior Regulatory Affairs Specialist to support the growth and expansion of our client's business.Job Summary:The successful candidate will be responsible for developing and implementing regulatory strategies to support the company's growth...
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Regulatory Affairs Lead
5 hours ago
Cork, Cork, Ireland Life Science Recruitment Full timeJob Overview:We are seeking a highly skilled Regulatory Affairs Lead to join our client's team.Key Responsibilities:Develop and implement a global regulatory strategyProvide strategic guidance to staff on regulatory process questionsMonitor regulations and the external environmentProvide technical support for regulatory and labelling-related systemsThe ideal...
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Regulatory Affairs Associate
7 days ago
Cork, Cork, Ireland Eli Lilly and Company Full timeAt Eli Lilly and Company, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our...
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Global Regulatory Affairs Lead
6 days ago
Cork, Cork, Ireland Hobson Prior Full timeCompany Overview:Hobson Prior is a leading global regulatory affairs company in the pharmaceutical and biopharmaceutical industries.We are seeking a highly skilled Lead Scientist to join our team and provide strategic guidance for the development of Chemistry, Manufacturing and Controls processes.The ideal candidate will have a deep understanding of...
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Director of Regulatory Affairs
6 days ago
Cork, Cork, Ireland Eli Lilly And Company Full timeOverviewEli Lilly And Company is a global healthcare leader committed to making life better for people around the world. Our mission is to unite caring with discovery, and we strive to deliver innovative solutions that improve human health.We are seeking an experienced Director of Regulatory Affairs to join our team. As a key member of our regulatory...