- System One (East Windsor, NJ)
- …position is responsible for creating a QA system to notify the US Food and Drug Administration ( FDA ) of illegitimate products, as and when needed. + This ... also review all finished product batches for compliance with applicable regulatory requirements and current Good Manufacturing Practice (cGMP) standards prior to… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …with US pharmacovigilance regulatory norm + Anchor drug safety regulatory inspection in US ( FDA regulatory agencies),participate in audits and ... identify and respond to signal analysis, and submit to regulatory agency ( FDA /Health Canada) within timelines to...medical Affairs and Medical Information activities. + Knowledge of FDA and Health Canada: Drug Discovery and… more
- Sanofi Group (Morristown, NJ)
- … Regulatory Responsibilities** + Reviews and validates clinical data compliance with FDA , EMA, and ICH regulatory standards through weekly data review ... program strategy and the network of collaborators from research to operational, regulatory , and commercial functions. Success in this role requires the ability to… more
- Bayer (Whippany, NJ)
- …and present clinical trial or section program-level data; + Proven experience with FDA regulatory requirements and ICH GCP guidelines for the development of ... design, execution, and oversight of the clinical development programs of diagnostic drug Molecular Imaging (MI) assets in Radiology. This role encompasses clinical… more
- Bristol Myers Squibb (Princeton, NJ)
- …environment, directly supporting Phase 1/2 patient selection and stratification drug studies. This role emphasizes immunohistochemistry (IHC) as the primary ... cytometry as valuable complements. You will ensure compliance with FDA 21 CFR Part 820, IVDR, CLIA, CAP, ISO13485,...LIMS, ELN, and clinical data management systems to support regulatory submissions and study execution. Project & CRO Management… more
- Merck (Rahway, NJ)
- …degree is preferred. + Leadership experience with working knowledge of device, biologic/ drug product, and process development including regulatory submission and ... & Process Development (DPPD) Team designs, develops, and commercializes novel biologic/ drug /vaccine - device enabled combination products to achieve safe and… more
- J&J Family of Companies (Titusville, NJ)
- …in Neurodegeneration, Neuroscience, with a focus on innovative late phase drug development for Alzheimer's Disease projects. They will provide strategic, clinical, ... quality monitoring & compliance, clinical supplies unit, TA strategy, regulatory affairs, data management, medical writing, biostatistics, global medical affairs,… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …approaches. + Ensure training content is accurate, current, and aligned with global regulatory requirements ( FDA , EMA, ICH). **Compliance & Risk Management** + ... and managing cross-functional teams. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Proven ability to… more
- Sanofi Group (Morristown, NJ)
- …and IVD products, intended to be used alone or in combination with a drug product, leading regulatory efforts in the development and post-marketing stages. The ... of medicine? The race is on to speed up drug discovery and development to find answers for patients...critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …other senior managers within R&D and across the enterprise in defining regulatory strategy, developing programs to support commercial strategy, building the pipeline ... external resources. Further responsibilities including leading the clinical contribution to regulatory filings and handling information requests from regulatory … more