43 Fda Jobs in County Dublin - page 4
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Regulatory Affairs Department Head Helsinn Birex Pharmaceuticals Ltd - Dublin pharmaceutical manufacturing plant, Helsinn Birex Pharmaceuticals Ltd (FDA and IMB approved) which has operated at Damastown Industrial Estate, Mulhuddart, since 1997. HBP develops, manufactures and packages 100000.0 15 days ago
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Regulatory Affairs Officer Ocumetra - Dublin will play a critical role in maintaining and enhancing our Information Security Management System (ISMS) and Quality Management System (QMS) and will take the lead in preparing our FDA submission More than 30 days ago
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Subject Matter Expert (SME) - Chemical API PM Group - Dublin to process facility design and construction is essential. Good appreciation of appropriate Regulatory framework, such as FDA, EMA, ICH Guidelines Find out more about PM Group and our projects. Why PM Group 12000.0 20 days ago
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Tech Transfer Lead PE Global - Dublin and procedures, including safety and training. Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & international standards) with a full understanding of CMC 22 days ago
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Drug Substance Process Scientist New CPL Recruitment - Dublin background in mammalian cell culture, protein purification or validation. · Good communication skills. · Experience of FDA and EU licensing and inspection support is desirable · Knowledge Negotiable 28 days ago
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CSV Engineer NeoDyne - Dublin, County Dublin, IE (FDS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Ensure compliance with GMP, GAMP 5, FDA 21 CFR Part 11, EU Annex 11 Competitive More than 30 days ago
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Contract Development & Mfg Sr Mgr Amgen - Dublin field Preferred Qualifications: 8+ years of experience in protein, API, DS, DP, or packaging manufacturing environment 8+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory 12000.0 25 days ago
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Senior Project Engineer Embecta - Dublin Experience with ISO requirements and GMP guidelines, FDA regulations, medical device design control, and manufacturing scale up processes Regular embecta is an Equal Opportunity/Affirmative Action Employer 12000.0 27 days ago
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Distribution Centre Manager Catalyx - North Dublin experience in medical device/pharmaceutical environment. Strong knowledge of GMP/GDP/FDA regulatory & Known Consignor, Warehouse housekeeping, Health & Safety. Excellent interpersonal and communication skills More than 30 days ago
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Global Head of Regulatory Affairs, Pharmaceuticals The Panel Group - Dublin and challenges in key markets. Provide strategic guidance on regulatory pathways and requirements for diverse international regions (e.g., FDA, EU, Canada, ROW, APAC, LATAM). Oversee the preparation and submission 29 days ago
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