- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …potentially formulation/fill-finish operations. + Experience with cGMP manufacturing environments and regulatory requirements ( FDA , EMA, ICH). + Familiarity with ... review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to downstream processing. +… more
- Novo Nordisk (Plainsboro, NJ)
- …within the organization. From health-care-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...of clinical and post marketing safety information with US drug and device safety reporting regulations and ICH guidelines… more
- J&J Family of Companies (Raritan, NJ)
- …of medical device regulations, standards, and regulatory bodies, eg FDA (Food and Drug Administration), ISO (International Organization for Standardization, ... Risk Management, Quality Engineering, Supply Chain, Quality Systems, Compliance, and Regulatory Affairs. + Identify and pursue design control system improvement… more
- Bayer (NJ)
- …timely and accurate implementation of new and revised labeling in accordance with FDA requirements and provides regulatory expertise and guidance for labeling ... evaluates requests for new or revised labeling initiated by FDA or Bayer HealthCare Pharmaceuticals and manages action required...using layman terms; + Solid knowledge of procedures in drug development and maintenance; + Analytical regulatory … 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
- Bristol Myers Squibb (New Brunswick, NJ)
- …technical expertise for evaluation and feedback of methods. + Ensure compliance with regulatory requirements (eg, FDA , EMA) and industry standards (eg, cGMP, ... equipment. This role is critical to ensuring compliance with regulatory standards and maintaining the highest levels of cleanliness...the CMC sub teams to ensure all API and drug product release testing, stability testing and filing requirements… more
- Sumitomo Pharma (Trenton, NJ)
- …and achieve goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, ... Provide clinical and medical expertise across all stages of drug development, from preclinical transition to post-marketing. + Stay... Interactions: + Prepare and present clinical data to regulatory agencies ( FDA , EMA) during IND submissions,… more
- J&J Family of Companies (Raritan, NJ)
- … and clinical requirements for diagnostics development and commercialization, including global regulatory frameworks (eg, FDA , EMEA, PMDA). + Proven ability to ... all assets within Heme, ensuring alignment with overall clinical development and regulatory activities. + Serve as the primary point of accountability for diagnostic… more
- Sanofi Group (Morristown, NJ)
- …relevant experience as Quality Auditor. + Direct experience preparing for and supporting Regulatory Inspections from Regulators (eg, US FDA , ANSM, PMDA, NMPA, ... secure product launches and support compliance through audits, inspections, regulatory surveillance, and advocacy. Grounded in core values Integrity, Collaboration,… 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