- Insmed Incorporated (NJ)
- …ensure efficient coordination of MRC activities, compliance with company policies and regulatory standards, and the quality and integrity of all reviewed materials. ... processes across global and regional teams, ensuring consistency and alignment with regulatory and company standards.Generate and present metrics and reports on MRC… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Proactively develops and sustains strong relationships with local/regional/national regulatory authorities.Analyzes regulatory authorities' programs and ... manufacturing compliance, clinical quality, or cell therapy.Knowledge of cGMP regulations and FDA /EU guidance related to manufacturing of cell based products as well… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will include but not limited to tasks mentioned above.Support regulatory inspections and audits as needed.Consistently perform tasks in adherence ... and cGMP requirements, as well as according to state and federal regulatory requirements.Other duties will be assigned, as the need arises.Job duties performed… more
- Eisai, Inc (Nutley, NJ)
- …learn about the efficacy and safety of Eisai's product(s) consistent with FDA approved label. Key job activities include territory and market analysis, strategic ... approved promotional clinical trials, patient access to medication, and regulatory /compliance guidelines. Strong knowledge of key laws and regulations impacting… more
- Merck & Co. (Rahway, NJ)
- …least 2 years GMP manufacturing/processing experience.- Familiarity with regulatory requirements and Good Documentation Practices (GDP).-Experience with some ... Degree in science or related field.BioWork Certificate (working in an FDA or similar regulated industry).Experience with automated systems (MES, SAP, or… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …resulting in the delay of investigation closure and product release.Support regulatory inspections and audits by ensuring inspection readiness within facility and ... serving as an SME during the execution of regulatory inspections and audits as needed.Support compliance activities for...or cell therapy.Knowledge of cGMP and GDP regulations and FDA /EU guidance related to manufacture of cell based productsGreat… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the optimization and efficient utilization of the warehouse space. Assist in regulatory inspections, perform safety and quality audits, and answer relevant questions ... Excel, PowerPoint, and Outlook) is required.Knowledge of cGMP regulations and FDA guidelines.Experience using material handling equipment, SAP, or similar inventory… more
- Eisai, Inc (Nutley, NJ)
- …strongly preferred Knowledge of treatment guidelines, clinical research processes, FDA regulations, pharma regulations/compliant practices, and OIG guidelines are ... work independently and not require close supervision while adhering to compliance/ regulatory policies. Interest in leading and participating in projects while… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …permanent inspection readiness and actively supports internal audits and regulatory inspections.Provides input to studies related to process improvement and ... and the ability to follow procedures.Knowledge of cGMP regulations and FDA guidance related to manufacturing of cell based products.Physical dexterity sufficient… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …collaboration across relevant cross functional groups to enable robust training, regulatory compliance, team readiness, and processing of product prior to release ... quality systems, or learning management systems.Knowledge of cGMP regulations and FDA /EU guidance related to manufacturing of cell based products as well… more
