Regulatory Affairs Expert
2 weeks ago
Astellas Ireland is committed to delivering high-quality treatments that make a meaningful difference in the lives of patients. Our vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience.
About the OpportunityThis is a unique opportunity to join a leading pharmaceutical company and contribute to the delivery of life-changing treatments. As a Quality Assurance Specialist, you will play a critical role in ensuring compliance with cGMP regulations and maintaining the integrity of our Quality Management System.
ResponsibilitiesYour key responsibilities will include:
- Developing and implementing procedures for cGMP compliance
- SUPPORTING inspection readiness by ensuring timely progression of eQMS records
- PROVIDING real-time support for manufacturing, QC, and operations
- REVIEWING and APPROVING SOPs and controlled documents for cGMP compliance
To be considered for this role, you should have prior experience working in a GMP environment, knowledge of regulatory requirements related to pharmaceutical manufacture, exceptional attention to detail, and proficiency in Microsoft Office Suite, including MS Excel. A third-level qualification in Science or Engineering discipline or equivalent is also required.
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Associate Director of Regulatory Affairs
6 hours ago
Ireland Regeneron Ireland DAC Full timeAbout the Role:We are seeking an experienced professional to fill the role of Associate Director, Gps Standards & Training at Regeneron Ireland DAC. As an Associate Director, Gps Standards & Training, you will play a crucial part in ensuring compliance with regulatory PV requirements worldwide and operating efficiently within established industry...
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Regulatory Affairs Manager
5 days ago
Ireland Astellas Ireland Full timeKey Skills and QualificationsTo be successful in this role, you will need:Knowledge of regulatory requirements related to pharmaceutical manufactureExceptional attention to detail and organisational skillsProficiency in Microsoft Office Suite, including MS ExcelExcellent communication and collaboration skillsPrior experience of working in a GMP...
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Regulatory Labeling Director
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Regulatory Affairs Professional
2 weeks ago
Ireland Astellas Ireland Full timeWhat We OfferAstellas Ireland offers a challenging and diversified job in an international setting, along with opportunities and support for continuous development. The inspiring work climate makes it an ideal place to grow and succeed.Equal Opportunities EmployerAstellas Ireland is an equal opportunity employer and all qualified applicants will receive...
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Quality Assurance Manager
6 hours ago
Ireland Regeneron Ireland DAC Full timeJob Specifications:We are seeking an experienced professional to join our team as an Associate Director, Gps Standards & Training at Regeneron Ireland DAC. The ideal candidate must have at least 7+ years of experience in Pharmacovigilance/Drug Safety, Regulatory Affairs, or Quality Assurance within the pharmaceutical/biotech industry, a Bachelor's degree is...
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Director, Regulatory Labeling
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Ireland Regeneron Ireland DAC Full timeThe Director, Regulatory Labeling manages the development, review, approval, and maintenance of the Company Core Data Sheets (CCDS), USPI, EU SmPC and Rest of World (RoW) labeling. Provides labeling expertise to the Labeling Working Group and other relevant stakeholders, carrying out responsibilities independently. Leads development of labeling strategies...
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Director, Regulatory Labeling
6 days ago
Ireland Regeneron Ireland DAC Full timeThe Director, Regulatory Labeling manages the development, review, approval, and maintenance of the Company Core Data Sheets (CCDS), USPI, EU Sm PC and Rest of World (Ro W) labeling.Provides labeling expertise to the Labeling Working Group and other relevant stakeholders, carrying out responsibilities independently.Leads development of labeling strategies...
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Director of Pharmacovigilance Operations
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Ireland Regeneron Ireland DAC Full timeJob Description:We are seeking a highly skilled professional to fill the role of Associate Director, Gps Standards & Training at Regeneron Ireland DAC. This position plays a crucial role in ensuring compliance with regulatory PV requirements worldwide and operating efficiently within established industry practices.The successful candidate will be responsible...
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Global Clinical Data Lead
2 weeks ago
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Clinical Data Flow Specialist
2 weeks ago
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Senior Quality Management Specialist
6 hours ago
Ireland Regeneron Ireland DAC Full timeOverview:Regeneron Ireland DAC is an innovative biopharmaceutical company that is committed to discovering and developing life-changing medicines. We are seeking a highly skilled professional to join our team as an Associate Director, Gps Standards & Training. In this role, you will play a crucial part in ensuring compliance with regulatory PV requirements...
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Manufacturing Operations Expert
5 hours ago
Ireland Astellas Ireland Full timeKey ResponsibilitiesIn this role, you will be responsible for ensuring compliance with GMP/GDP requirements for our Aseptic fill-finish facility. This will involve working closely with various departments to develop and implement operational procedures for best practice and regulatory compliance.Main ResponsibilitiesYour key responsibilities will include:...