- Leica Biosystems (Miami, FL)
- …would be a plus if you also possess previous experience in:Familiarity with regulatory tools and systems , including eQMS platforms (eg, IQVIA), EUDAMED, and ... about the Danaher Business System which makes everything possible.The Senior Regulatory Affairs Specialist I is responsible for for pre-market regulatory… more
- Merck & Co. (Rahway, NJ)
- … Compliance, Regulatory Labeling, Regulatory Operations, Regulatory Submissions, Strategic Thinking, Systems Development Lifecycle (SDLC), Vendor ... experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement experience… more
- Pall (Miami, FL)
- …will be a strategic leader with deep expertise in quality systems , regulatory compliance, manufacturing, and cross-functional collaboration.This position reports ... & Beverage, Military, Electronics, Paper, etc.. ).Strong knowledge of quality systems , regulatory standards, and industry best practices.Proven leadership,… more
- Merck & Co. (Upper Gwynedd, PA)
- …responses to health authority questions per established business processes and systems .-Identify, communicate and escalate potential regulatory issues to GRACS ... Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description:The Vice President, Regulatory Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory ... strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.Contributing to the continuous improvement of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory ... Process Excellence & Analytics function, responsible for ensuring Daiichi Sankyo's Regulatory processes & procedural documentation are fit for purpose and compliant… more
- Cepheid (Miami, FL)
- …in field with 2+ years of related work experience.Functional knowledge of Quality, Regulatory Compliance, and operations systems and processes to include GMP and ... Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you'll get to make an… more
- Twist BioScience (South San Francisco, CA)
- The Regulatory Operations Specialist is responsible for ensuring the efficient and compliant management of regulatory documentation, with a primary focus on ... global product compliance, ensuring that all documentation accurately reflects regulatory requirements and product specifications.What You'll Be Doing Initiate,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in overseeing the development, validation, implementation, and integration of GxP-regulated systems across the organization. This position ensures that all global ... systems , electronic records, validation processes, and regulated applications meet...electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards.… more
- Merck & Co. (Rahway, NJ)
- …infrastructure at the Rahway (RY) NJ Campus. - This role ensures HVAC systems comply with regulatory standards (eg, FDA, cGMP), maintain optimal environmental ... People Leadership, Plant Maintenance, Preventative Maintenance Programs, Process Control Systems , Project Management, Regulatory Compliance, Regulatory … more
- Pall (Miami, FL)
- …safety and environmentally responsible technologies. From airplane engines to hydraulic systems , scotch to smartphones, OLED screens to paper-everyday Pall is there, ... Business System which makes everything possible.Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets federal/state/international regulations as they apply to… more
- Leica Biosystems (Miami, FL)
- …about the Danaher Business System which makes everything possible.The Specialist, Regulatory Compliance for Leica Biosystems is responsible for working with ... System (QMS) to ensure ongoing compliance while continuing to develop regulatory affairs skills.This position reports to the Director, Quality Assurance and… more
- Cepheid (Miami, FL)
- …Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you'll get to make an ... about the Danaher Business System which makes everything possible.The Regulatory Affairs Principal is responsible for serving as RA...projects and/or system projects.This position reports to the Director Regulatory Affairs, NPD and is part of the … more
- Cytiva (Pensacola, FL)
- …site's Quality Management Representative, leading QA/QC functions, ensuring regulatory compliance, and aligning with organizational quality goals.Quality Management ... optimize the Cytiva QMS, ensuring procedures, work instructions, and IT systems support site operations and drive continuous improvement.Strategic Partnership &… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and internal stakeholders to execute audits effectively. Ensure the internal systems auditing program fulfills regulatory requirements performs audits, ... responsible for end-to-end GxP relevant audit activities that encompasses the internal systems and processes of the Daiichi Sankyo's GxP group.Together with regional… more
- Cepheid (Miami, FL)
- …about the Danaher Business System which makes everything possible.The Senior Quality Systems Specialist is responsible for functioning as Lead Internal Auditor to ... and implement improvements. This position will work with the Senior Manager Quality Systems Compliance.This position is part of the Quality department and will be… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …instrumentation, automation PLCs, VFDs and electrical practicesComputerized maintenance management systems (CMMS)EHS and regulatory standards (eg EPA, OSHA ... provide start-up, commissioning, and qualification/validation support of instrumentation and systems including on-the-floor troubleshooting of equipmentPromotes a collaborative work… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and Skills:cGMP manufacturingMaintenance, facilities and utilitiesComputerized maintenance management systems (CMMS)EHS and regulatory standards (eg EPA, ... pipefitting, and millwright activities associated with the related mechanical systems , utilities, and process equipmentPerform minor upgrades and installations of… more
- Aldevron (Miami, FL)
- …position.Experience with final drug product manufacturing with incoming Quality Management Systems , Quality Assurance and regulatory audits required.Bachelor of ... Quality and release processes in compliance with all foreign and domestic regulatory and statutory requirements. This individual will help to provide the strategic… more
- Merck & Co. (Rahway, NJ)
- …the disposition of API materials to ensure conformance to appropriate regulatory and company requirements for clinical supply manufacture and/or regulatory ... performs audits of batch documentation, data, information, procedures, equipment and systems , and/or facilities to ensure the compliance with Standard Operating… more
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