- IQVIA (San Francisco, CA)
- …to make a significant impact in the field. A strong background in current FDA regulatory expectations and the global landscape in Oncology is preferred. ... and identifying new business opportunities. + Provide due diligence scientific, medical, regulatory , and drug development expertise and activities for IQVIA or… 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
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …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
- 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
- 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
- ThermoFisher Scientific (Santa Clara, CA)
- …*Must be able to pass a comprehensive background check, which includes a drug screen. **Discover Impactful Work:** This role requires a hands-on professional with a ... assurance. The ideal candidate will have a firm grasp of ISO and FDA regulations and the ability to lead investigations and continuous improvement initiatives across… more
- Actalent (Fountain Valley, CA)
- …team, pharmaceutical sponsors, and research participants, ensuring compliance with regulatory standards. It requires a strong medical experience, proficiency in ... Good Clinical Practices (GCP), FDA regulations, and a commitment to ethical research standards. Responsibilities + Manage and oversee the execution of clinical… more
- Stanford University (Stanford, CA)
- …Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. Submit Investigational New Drug applications to the FDA ... and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. + Knowledge… more
- Abbott (Alameda, CA)
- …and other regulatory requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, ... the requirements of the quality system, as well as FDA , ISO, MDD, CDR, MHLW, and other regulations applicable...industry + Min 8 years auditing per ISO and/or FDA standards. + Knowledge of MDD, CMDR, MHLW, TGA,… more
- Stanford University (Stanford, CA)
- …regulatory compliance. + Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure ... and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. IRB… more