- 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
- 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
- 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
- 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
- BioAgilytix (Durham, NC)
- …that boost lab productivity and keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational data ... build quality assurance processes, and monitor data integrity to meet regulatory requirements, including HIPAA, GxP, GDPR, and FIRPA.Design data quality KPIs… 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
- Aequor (Athens, GA)
- …and Clean Utilities including: plumbing, mechanical, electrical, HVAC, high purity water systems , clean steam, cold storage, fire systems and compressed air. ... Conduct regular inspections and preventative maintenance to ensure systems are operating efficiently and safely. Engage in technical activities/troubleshooting… more
- Twist BioScience (South San Francisco, CA)
- …of our proprietary MES technologies will ensure strict adherence to regulatory requirements, optimize complex biological manufacturing processes, and align with our ... continuous improvement, technical excellence, robust software development practices, and regulatory compliance.Software Development & Implementation: Oversee the full Software… more
- Insmed Incorporated (San Diego, CA)
- …of Clinical Quality Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality lead on the gene therapy ... This role provides support and promotes collaboration internally to ensure all systems , processes and their outcomes comply with applicable international and … more
- Merck & Co. (Rahway, NJ)
- …in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination products.The incumbent must be able to lead ... full integration of the device development activities with the clinical, regulatory , formulation, commercial and other key company functions.Lead the Device… 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
- Insmed Incorporated (San Diego, CA)
- …process development support testing function within analytical development. Will develop systems and processes to facilitate rapid, high throughput testing. As the ... technical issues. Contributes to method qualification and validation according to regulatory guidelines such as ICH, FDA, and cGMP, evaluating method characteristics… 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
- Eisai, Inc (Chicago, IL)
- …develop and implement account specific strategies to meet objectives for assigned Health Systems . This role serves as the primary point of contact between Eisai and ... formulary decision-makers within identified Health Systems representing Eisai's product portfolio.The Health System Account Executive will be responsible for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …providing quality oversight over the validation and qualification activities for equipment, systems , computer systems , and processes within a cell therapy ... studies, and any associated documentation in support of computer systems validation, equipment, utilities, and facility qualification, process validation, shipping… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor various ... and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA, EMA, and other global regulatory… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible for… more
