- 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. (Rahway, NJ)
- …and process validation, with a strong understanding of quality management systems and regulatory compliance.Exceptional project management skills and principled ... products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems . The director will lead a team of engineers and technical staff to… 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
- 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)
- …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
- Radiant (El Segundo, CA)
- …or disaster-relief scenarios. Engineer - Regulatory Radiant is seeking a driven Regulatory Systems Engineer who loves to think outside the box and challenge ... role you will support the license application approval process with the Nuclear Regulatory Commission. This role is critical to bringing the world's first portable… more
- Katalyst HealthCares and Life Sciences (Irvine, CA)
- …creating and/or maintaining CCDS/CCSI/RSI documentation, delivering, maintaining, and driving regulatory systems , databases, and labeling processes that support ... Responsibilities: The Regulatory Affairs Manager is responsible and accountable for...track status and maintain documents in controlled process and systems workflows; lead reviews and manage the documents through… 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
- 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
- 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
- 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 ... role provides support and promotes collaboration internally to ensure all systems , processes and their outcomes comply with applicable international and national… 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
- Santander Holdings USA Inc (Boston, MA)
- …assessment and oversight for electronic payments projects, ensuring compliance with regulatory requirements, Payment Systems Risk Policy, Standards, and internal ... trends, regulatory changes, and best practices related to payment systems and operational risk management. Prepare and present risk assessment reports to… more
- LENZ Therapeutics, Inc. (Solana Beach, CA)
- …regulatory submissions, supporting the implementation and maintenance of our Regulatory Information Management and publishing systems , and ensuring compliance ... regulatory guidelines and internal standards. Maintain submission tracking systems to monitor submission status and timelines, proactively identifying and… more
- Merck & Co. (Durham, NC)
- …technology transfer focusing on either upstream, downstream, and/or culture media/support systems . Off-shift and weekend coverage will be required based on business ... qualification studies associated with the development and implementation of processes, systems and facilities related to vaccine drug substance and key intermediates… more
- Parallel Systems (Los Angeles, CA)
- …IEC 61508, or other functional safety frameworks Hands-on experience leading systems through regulatory testing and certification processes Working knowledge ... Parallel Systems is pioneering autonomous battery-electric rail vehicles designed...with mechanical, software, and autonomy components and subject to regulatory oversight. The ideal candidate brings automotive or vehicle… 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
- Merck & Co. (Rahway, NJ)
- …critical role in driving member satisfaction, improving efficiencies, and ensuring regulatory compliance while advancing the credit union's payments strategy in ... with overall business goals and member needs.Monitor industry trends, emerging technologies, and regulatory changes to keep the credit union on the cutting edge of… more
