- Legend Biotech USA, Inc. (Raritan, NJ)
- … as part of the Quality team based in Raritan, NJ. Role OverviewThe Quality Compliance Manager is responsible for regulatory compliance supporting the ... and independent audits; manage audit responses and observation resolution.Drive site compliance to regulatory , enterprise, and global requirements through… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference? The Position We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical tasks ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...regulatory guidance on commercial labeling materials to ensure compliance with CFR and FDA labeling requirements Identify labeling… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and initiatives to develop solutions to promotional issues, while ensuring regulatory compliance and effectively managing business risks Creatively advise ... advise on mitigation strategies to meet overall business need, while maintaining compliance with US regulatory requirements and company operating procedures… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a QA Laboratory Compliance Manager as part of the Quality team based in Raritan, NJ. ... Role OverviewThe QA Laboratory Compliance Manager role is an exempt level position with responsibilities for providing quality oversight over the compliance … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory labeling-related activities. Updates internal processes to ensure compliance with health authority requirements and expectation Physical Requirements ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Affairs, CMR, Supply Chain, and HQ colleagues regarding labeling compliance to accomplish company goals. External relationships may include… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …experience within regulated industries A minimum of 6 years combined pharmaceutical, legal, regulatory , and compliance experience required OR a minimum of 3 ... the Department At Novo Nordisk, we're committed to building the best Ethics, Compliance & Privacy (ECP) team in the pharmaceutical industry. Operating at the highest… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulatory standards, contributing to the organization's success and regulatory compliance .ResponsibilitiesCoordinate global regulatory dossier generation ... and immune disorders. Summary The purpose of the Project Manager (RACMC) function is to lead and/or support complex...is to lead and/or support complex filing activities, ensuring compliance with technical and regulatory standards. This… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …requirements.Strive to reduce non-conformances in supported areas by dedicatedly driving compliance .Ensure readiness of records for regulatory inspections and ... treatment of multiple myeloma.Legend Biotech is seeking a QA Batch Warehouse Associate Manager as part of the Quality team based in Raritan, NJ. Role OverviewThis… more
- Merck & Co. (Rahway, NJ)
- …with Clinical Supply Planning, Clinical Operations, Country Operations, CRO, Regulatory , Trade Compliance , Global Logistics, and third-party providers.Preferred ... Job DescriptionThe Transportation Manager will be responsible for supporting and work...Operations, Country Clinical Operations, CMOs/CROs, Logistics, Security, and Trade Compliance .- To support the distribution for Clinical Trial Material… more
- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems ... incumbent uses systems thinking and a holistic systems-based approach to drive compliance and assess operational needs and activities in to accurately, effectively,… more
