- 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
- J&J Family of Companies (Danvers, MA)
- …risk management tools and methodologies (FMEA, FTA). + Experience supporting regulatory submissions and preparing verification packages for FDA /Notified Body ... devices. You will lead design verification activities in preparation for regulatory submissions and work closely with electrical, mechanical, software, and clinical… more
- Grifols Shared Services North America, Inc (Van Nuys, CA)
- …and ensures compliance with state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedures, Occupational Safety and ... standards in accordance with state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedures, Occupational Safety and… more
- Cytel (Charleston, WV)
- …and associates across Cytel. + Maintain strong engagement with senior client leadership, regulatory agencies ( FDA /EMA), and key opinion leaders to support and ... junior colleagues, and driving high-impact consulting engagements. + Experience interacting with regulatory agencies ( FDA /EMA) and key opinion leaders to shape… more
- Curia (Albuquerque, NM)
- …effective corrective and preventive actions + Participate in on-site customer and regulatory agency inspections (eg, FDA , EMA, PMDA, CFDA), presenting quality ... of quality and compliance in the manufacturing of parenteral sterile drug products. This role involves developing, implementing, and continuously improving… more
- Allucent (Cary, NC)
- …you won't just observe - you'll contribute, learn, and grow alongside experts shaping drug development and regulatory strategy. This role is for a summer ... modeling reports, INDs, clinical pharmacology sections of NDAs, Investigator Brochures, FDA briefing packages, and other clinical and regulatory documents… more
- Takeda Pharmaceuticals (Boston, MA)
- …robustness and supply continuity. As needed, you will represent Small Molecule Drug Substance in forums with partners including Regulatory , Quality, Analytical ... reports + investigation reports and technical reports supporting submissions + Provide regulatory CMC support by authoring/reviewing drug substance (and relevant… 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
- Otsuka America Pharmaceutical Inc. (Richmond, VA)
- …approaches. + **Compliance & Risk Management** + Ensure all training programs meet global regulatory standards ( FDA , EMA, ICH, etc.) and internal SOPs. + Monitor ... focus on GxP compliance and training. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Proven ability to design… more
- GRAIL (Durham, NC)
- …process optimization experience, and a thorough understanding of clinical laboratory regulatory frameworks. This position is **onsite full-time** , with **5 days ... validation protocols and procedures in compliance with CLIA, CAP, NYS, ISO 13485, FDA , and other applicable standards. + Provide scientific and technical support to… more