Global Regulatory Manager
6 days ago
Eli Lilly And Company is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. As a member of our team, you will have the opportunity to contribute to our mission of making life better for people around the world.
We are seeking an experienced Regulatory Scientist to join our team in Cork. As a CMC Regulatory Expert, you will be responsible for 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.
You will work closely with GRA-CMC Regulatory Scientists to manage outsourcing activities & contract manufacturers, ensure successful preparation of CMC dossiers and variation packages to support product submissions, and provide regulatory leadership and support for products listed as the primary responsibilities.
A key aspect of this role is developing, planning and executing appropriate regulatory strategies and on agreed-upon priorities through effective partnership with GRA-CMC Regulatory Scientists and other functional representatives, such as TS/MS (process and technology transfers), manufacturing, quality control and quality assurance.
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Global Regulatory Strategy Manager
4 hours ago
Cork, Cork, Ireland Life Science Recruitment Full timeAbout the Position:This is an exciting opportunity for a Global Regulatory Strategy Manager to join our client's team.Key Responsibilities:Recruit and develop a diverse workforceEnsure robust individual training plans and timely completion of required training for direct reportsSupport talent identification and career developmentActively coach and mentor...
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Global Regulatory Specialist
5 days ago
Cork, Cork, Ireland Hero Recruitment Full timeGlobal Regulatory Affairs-CMC Job Description:This role is responsible for providing strategic direction to expedite CMC development of the portfolio and technical agenda. This includes supporting global clinical trial, market registration submissions, and post-approval submissions.Main Responsibilities:Oversee the preparation and documentation of specified...
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Cork, Cork, Ireland Eli Lilly And Company Full timeDuties and ResponsibilitiesThis role requires strong leadership and technical skills to develop and maintain global labeling. Key duties include:Developing and implementing global labeling strategies to facilitate simultaneous global submissions.Leading the development and maintenance of core labeling documents.Communicating with global affiliates to ensure...
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Global Regulatory Lead
6 days ago
Cork, Cork, Ireland Eli Lilly and Company Full timeWe are seeking a highly skilled Global Regulatory Lead to join our team and lead the development and implementation of regulatory strategies that drive business success. The successful candidate will have a strong background in regulatory affairs, with experience in developing and executing regulatory strategies for pharmaceutical products.The Global...
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Global Regulatory Specialist
13 hours ago
Cork, Cork, Ireland HERO Recruitment Full timeJob Summary:This is a hybrid role, located in Cork, Ireland. As a Senior Regulatory Affairs Specialist with our client, you will provide strategic, tactical, and operational direction to expedite CMC development of the portfolio and technical agenda by supporting global clinical trial, market registration submissions, and post-approval submissions.Oversee...
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Regulatory Lead for Global Labeling
7 days ago
Cork, Cork, Ireland Life Science Recruitment Full timeJob Summary:The Regulatory Lead for Global Labeling will play a critical role in ensuring the development and maintenance of global labeling, including all core labeling documents related to drug, device, CMC, and carton/container components.This position is responsible for leading the development and implementation of global labeling strategy to facilitate...
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Global Regulatory Insights Specialist
4 days ago
Cork, Cork, Ireland Remitly, Inc. Full timeThe RoleWe are seeking a Global Regulatory Insights Specialist to join our Analytics team.In this role, you will be responsible for building a global regulatory reporting program that enables our compliance function to scale through data.You will partner with compliance officers, program managers, analysts, and operational teams across the globe to develop...
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Associate Director Global Regulatory Affairs
2 weeks ago
Cork, Cork, Ireland Life Science Recruitment Ltd Full timeAssociate Director Global Regulatory Affairs Our client, a global pharma company, are currently recruiting for an Associate Director Global Regulatory Affairs to join their team on a permanent basis. People management experience is essential for this role. This role offers hybrid working. Responsibilities: People Management: Recruit, develop, and retain a...
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Associate Director Global Regulatory Affairs
6 days ago
Cork, Cork, Ireland Life Science Recruitment Ltd Full timeAssociate Director Global Regulatory Affairs Our client, a global pharma company, are currently recruiting for an Associate Director Global Regulatory Affairs to join their team on a permanent basis.People management experience is essential for this role.This role offers hybrid working.Responsibilities: People Management: Recruit, develop, and retain a...
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Associate Director Global Regulatory Affairs
2 weeks ago
Cork, Cork, Ireland Life Science Recruitment Full timeAssociate Director Global Regulatory AffairsAssociate Director Global Regulatory AffairsOur client, a global pharma company, is currently recruiting for an Associate Director Global Regulatory Affairs to join their team on a permanent basis. People management experience is essential for this role. This role offers hybrid working.Responsibilities:People...
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Associate Director Global Regulatory Affairs
6 hours ago
Cork, Cork, Ireland Life Science Recruitment Full timeAssociate Director Global Regulatory AffairsAssociate Director Global Regulatory AffairsOur client, a global pharma company, is currently recruiting for an Associate Director Global Regulatory Affairs to join their team on a permanent basis. People management experience is essential for this role. This role offers hybrid working.Responsibilities:People...
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Global Regulatory Strategist
4 days ago
Cork, Cork, Ireland Eli Lilly And Company Full timeAs a key member of our team, you will be responsible for providing strategic, tactical, and operational direction and support to deliver global regulatory strategies from candidate selection to clinical proof of concept for assigned assets.This role requires strong leadership abilities/behaviors, particularly entrepreneurial mindset, strategic thinking, and...
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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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Global Regulatory Program Lead
2 days ago
Cork, Cork, Ireland Apple Inc. Full time**About Apple Inc.**We deliver innovative products, technologies, and services to inspire creativity and enrich lives. At Apple, we strive for excellence in every aspect of our business.The ideal candidate will lead regulatory projects, navigate conflicts, and drive project plans through effective resource allocation and risk management.This role requires a...
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Global Regulatory Leader ExploR&D
5 days ago
Cork, Cork, Ireland Eli Lilly and Company Full timeEli Lilly and Company is a global healthcare leader dedicated to improving human life. Our employees work together to discover and bring life-changing medicines to those who need them. We prioritize diversity, equity, and inclusion (DEI), catering to all dimensions and promoting accessibility for all.This posting is for a fixed-term position supporting...
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Global Regulatory Compliance Specialist
7 days ago
Cork, Cork, Ireland Eli Lilly and Company Full timeEli Lilly and Company is committed to helping individuals with disabilities participate in the workforce and ensuring equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources for further assistance. Please note This email address is intended for use only to request an...
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Global Regulatory Affairs Professional
4 days ago
Cork, Cork, Ireland Pale Blue Dot®Recruitment Limited Full timeAbout the Opportunity:Pale Blue Dot Recruitment is seeking a talented Global Regulatory Affairs Professional to join our client's team. The successful candidate will be responsible for developing and implementing regulatory strategies to support the timely and successful registration, approval, and maintenance of company and client products.The ideal...
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Regulatory Compliance Manager
2 weeks ago
Cork, Cork, Ireland Fastnet Full timeAssociate Director/Director, Regulatory CMCThe position requires knowledge and experience of biologics and/or pharmaceuticals and preferably gene therapy medicinal products. The incumbent must possess technical expertise in the area of responsibility and demonstrate effective problem-solving, strong understanding of global regulatory affairs submissions and...
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Global Regulatory Affairs Director
1 day ago
Cork, Cork, Ireland Eli Lilly and Company Full timeAt Eli Lilly and Company, we are a global healthcare leader committed to making life better for people around the world. Our mission is to unite caring with discovery to bring innovative medicines and solutions to those who need them most.About UsWe are headquartered in Indianapolis, Indiana, but our impact is felt globally. Our diverse team of over 1,400...
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Cork, Cork, Ireland Life Science Recruitment Full timePrincipal Scientist Global Regulatory Affairs CMCPrincipal Scientist- Global Regulatory Affairs-CMCOur client, a global pharma company, is currently recruiting for a Principal Scientist- Global Regulatory Affairs-CMC for their Cork based manufacturing site.This is a permanent role with hybrid working.As Principal Scientist- Global Regulatory Affairs-CMC, you...