- 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)
- …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. (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 ... This role provides support and promotes collaboration internally to ensure all systems , processes and their outcomes comply with applicable international and … 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
- 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
- Eisai, Inc (Boston, MA)
- …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
- 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …as a lead GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines ,- strategies ... the efficiency, accuracy, and effectiveness of clinical supply planning processes and systems . - Stay updated on industry trends, regulations, and best practices… more
- Merck & Co. (Rahway, NJ)
- …process validation, second generation process development and authoring of regulatory submissions.-Under the general scientific and administrative direction of the ... next generation process development and characterization, process validation, and regulatory submission authoringIn this role, the successful candidate will be… 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
- 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
