- United Therapeutics (Christiansburg, VA)
- …facility + Experience interfacing with the US Food and Drug Administration ( FDA ) and, as appropriate, ex/US regulatory agencies + Strong knowledge of cGMP ... their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial… 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
- IQVIA (Washington, DC)
- …significant impact in the field. A strong background in current FDA regulatory expectations and the global landscape in ... and identifying new business opportunities. + Provide due diligence scientific, medical, regulatory , and drug development expertise and activities for IQVIA or… more
- Genentech (South San Francisco, CA)
- …pharmaceutical, biotech, or CRO settings. + You are familiar with ICH guidelines, GCP, and regulatory requirements such as FDA and EMA. + You have a strong ... + Familiarity with innovative design methods (eg, Bayesian designs, model-informed drug development) and regulatory expectations for exploratory endpoints. +… more
- Bristol Myers Squibb (San Diego, CA)
- …on global regulatory matters relevant to radiopharmaceuticals, including FDA regulations governing drug development, clinical trials, approval, labeling, ... experience in the biotech, pharmaceutical or life sciences industry, including significant FDA regulatory and healthcare law counseling. + Prior experience… more
- Cedars-Sinai (Los Angeles, CA)
- …Ensures compliance with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. + Maintains ... for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact as needed for… more
- System One (Diamondhead, MS)
- …ensures that all study activities are performed in compliance with ICH-GCP, FDA , and institutional standards, prioritizing participant safety, data integrity, and ... regulatory compliance. The PI serves as the main point...ensure GCP compliance. + Oversee investigational product management, including drug accountability and storage. + Review and sign off… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …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
- 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