- Merck & Co. (Rahway, NJ)
- …US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.Contributing to the continuous improvement of the operating ... activities in the US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and compliant with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality , CSPV, Clinical Operations, ... regulatory procedural documentation, in line with company-wide policy and relevant regulatory requirementsCoordinate with broader DS quality teams to support… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Repligen (Waltham, MA)
- …manage Supplier Change Notifications to ensure compliance with internal and regulatory quality standards.Coordinate cross-functional teams to assess and mitigate ... accountability, supporting root cause investigations, and ensuring Repligen's supplier network meets regulatory and quality standards. This role is based in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Twist BioScience (South San Francisco, CA)
- …closely with the platform architecture and infrastructure teams, Manufacturing Operations, Quality Assurance, Process Development, and Regulatory Affairs teams ... platforms (eg, AWS, Azure, GCP) and DevOps practices.Direct experience participating in regulatory audits (eg, FDA inspections) specifically related to custom… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for ... design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the … more
- Merck & Co. (Rahway, NJ)
- …for FDA e-data mailboxes (CBER/CDER), attendance at meetings with regulatory agencies ( FDA , EMA, PMDA),Guiding project teams preparing submission ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (Rahway, NJ)
- …particularly in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination products.The incumbent ... knowledge of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Companion Diagnostic productsProven experience with Health Authority Inspections, (eg, FDA , HPFB, MHRA and other European regulatory agenciesInternational ... audits effectively. Ensure the internal systems auditing program fulfills regulatory requirements performs audits, identifies compliance issues and trends, reviews… more
- Merck & Co. (Rahway, NJ)
- …controls areaKnowledge of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA ... from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.This position will interact… more
- Merck & Co. (Rahway, NJ)
- …( our Manufacturing Division / our Research & Development Division ) such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of ... of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory , Operations, Non-clinical, Clinical, and other functional… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …performance, and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA , EMA, and other global ... size.Responsible for multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics; these metrics will… more
- Formation Bio (New York, NY)
- …role in scaling our biologics capabilities in partnership with technical, quality , and regulatory leaders.Responsibilities Strategic Leadership Develop and ... Collaboration & External Partnerships Partner closely with analytical development, manufacturing, quality , and regulatory teams to ensure seamless execution of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Companion Diagnostic products preferredProven experience with Health Authority Inspections, (eg, FDA , HPFB, MHRA and other European regulatory agencies) ... File (eTMF) and other pivotal documents to be submitted to the regulatory authorities for application Qualifications: Successful candidates will be able to meet… more
- Tris Pharma (Monmouth Junction, NJ)
- …coordinates and advances required documentations, in liaison with Product Development (PD)/ Quality Assurance (QA)/ Quality Control (QC)/ Regulatory Affairs, ... required documentations and change control activities, in liaison with PD/QA/QC/ Regulatory AffairsDesigns experimental plans; Critically analyzes data and information… more
- BioAgilytix (Durham, NC)
- …tools that boost lab productivity and keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a ... at diagnosing data challenges and designing innovative solutions to improve data quality , integration, and regulatory adherence.Capable of growing with the role… more
- Aequor (Hicksville, OH)
- …all applicable procedures, cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA , EMEA, ANVISA, HS&E, etc.). Ensures all ... in a safe, effective manner, and in compliance with the appropriate industry and regulatory ( FDA , DEA, OSHA) standards, and Departmental, Plant, and Corporate … more
- Aequor (Hicksville, OH)
- …all applicable procedures, cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA , EMEA, ANVISA, HS&E, etc.). Ensures all ... in a safe, effective manner, and in compliance with the appropriate industry and regulatory ( FDA , DEA, OSHA) standards, and Departmental, Plant, and Corporate … more
