- Kelly Services (South San Francisco, CA)
- **Kelly(R) Science & Clinical ** is seeking a Regulatory Affairs Manager for a direct-hire position at a cutting-edge client in South San Francisco, CA . If ... step in your career, trust **The Experts at Hiring Experts.** **Manager, Regulatory Affairs** At Veracyte, we offer exciting career opportunities for those… more
- Ascendis Pharma (Palo Alto, CA)
- …and regulatory colleagues. + Contributes to the development of global clinical regulatory plans and strategies, identifies, and proposes risk mitigation ... implementing global regulatory strategies with focus on America's and the clinical , and non- clinical disciplines. Ensures timely preparation of organized and… more
- Merck (San Diego, CA)
- …+ Conduct initial content review and approval for IND/CSA submissions to enable clinical trial initiation. + Participate in regulatory due diligence activities ... chemistry, or related discipline with 10+ years of relevant drug development, clinical , or regulatory experience. + MD or Ph.D./Pharm D with 7+ years of… more
- Abbott (Sylmar, CA)
- …Leads various study support groups and cross-functional teams in order to develop clinical strategy. Interacts with regulatory agencies as needed, and will use ... R&D, Quality Engineering, Product Performance Group, Risk Management) clinical - regulatory organization, and some interactions with principal investigators… more
- GRAIL (Menlo Park, CA)
- …Requirements:** + **Experience** + Minimum of 8 years of experience in regulatory , development, clinical affairs, quality, or program management within the ... Affairs Certification (RAC) preferred. + Experience in pharmaceutical clinical , statistical, or regulatory settings-especially in oncology, immunology,… more
- GRAIL (Menlo Park, CA)
- …+ Thorough knowledge of GCP, ICH guidelines and other US and international clinical regulatory requirements + Working experience with an electronic data capture ... and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome… more
- Lilly (San Diego, CA)
- … studies that efficiently test therapeutic hypotheses + Collaborate with clinical pharmacology, biostatistics, regulatory affairs, operations, and other ... (biologics, small molecules, cell therapies, genetic medicines) + Knowledge of regulatory requirements for early clinical development (IND strategy, FDA… more
- Sumitomo Pharma (Sacramento, CA)
- …and tactical advancement of the clinical programs, and liaises with Clinical (including Clinical Operations), Biometrics, Regulatory , Early Clinical ... data analysis. + Provide medical expertise to cross-functional teams, including regulatory , commercial, and clinical operations. + Provide day-to-day practical… more
- Amgen (Thousand Oaks, CA)
- …quality of clinical data collection, processing, and analysis to support regulatory submissions and clinical development programs. This role is responsible ... and phases. This AVP will collaborate closely with cross-functional teams including clinical operations, biostatistics, regulatory affairs, and quality to drive… more
- Children's Hospital Los Angeles (Los Angeles, CA)
- …of care delivery within the Transplant Service to include but not limited to clinical , regulatory , compliance, and quality of care. The position has matrixed ... care that is personal, convenient and empowering. Our scientists will work with clinical experts to take laboratory discoveries and create treatments that are a… more