- Sumitomo Pharma (Sacramento, CA)
- …clinical regulatory strategies including management of IND and NDA submissions, FDA and other global regulatory interactions, as well as international ... to support proposed claims and assess consistency of proposed claims with FDA -approved labeling + Provide regulatory leadership to the respective… more
- Oracle (Sacramento, CA)
- …for Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring ... Excellent cross-functional communication and documentation skills. Preferred: . Experience supporting regulatory submissions or audits (EU MDR, FDA 510(k),… more
- Oracle (Sacramento, CA)
- …for Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring ... Excellent cross-functional communication and documentation skills. Preferred: . Experience supporting regulatory submissions or audits (EU MDR, FDA 510(k),… more
- Bristol Myers Squibb (San Diego, CA)
- …experience in the biotech, pharmaceutical or life sciences industry, including significant FDA regulatory and healthcare law counseling. + Prior experience ... quality, supply chain, and commercial functions. + Advise on global regulatory matters relevant to radiopharmaceuticals, including FDA regulations governing… more
- 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. ... from discovery to market. You will oversee preclinical strategy, clinical strategy, regulatory strategy, and commercial strategy, and assess the risk and probability… more
- Genentech (South San Francisco, CA)
- …and partnerships; + Advising regulatory , medical affairs, and other clients on FDA regulatory submissions, label negotiations and privacy and data use; + ... product sales and marketing, commercial strategic and operational functions, regulatory , market access (patient access, pricing, contracting and distribution), US… more
- Hologic (San Diego, CA)
- …input for audits and FDA submissions. + Maintain current knowledge of FDA and other regulatory body's cybersecurity guidance and standards, such as ISO, ... regulated environment is required. + Thorough familiarity with FDA and other regulatory body Cybersecurity Guidelines and cybersecurity standards such as NIST,… more
- Parexel (Sacramento, CA)
- …related industry experience. * Direct experience in advertising and promotional regulatory review. * Familiarity with FDA regulations governing promotional ... timelines. * Excellent communication skills, with the ability to explain regulatory concepts, including FDA regulations/guidances, clearly to cross-functional… more
- Oracle (Sacramento, CA)
- …all device software, ensuring vulnerability management and cybersecurity compliance with FDA and global regulatory expectations. + Apply the organization's ... standards such as IEC 62304, IEC 82304, and relevant FDA guidance. + Proven ability to apply regulatory... FDA guidance. + Proven ability to apply regulatory requirements to software design, documentation, and development practices.… more
- Stanford University (Stanford, CA)
- …including project management in a dynamic research setting. + Strong knowledge of regulatory affairs, including FDA regulations, IRB review and approval process, ... Regulatory Specialist (Hybrid Opportunity) **School of Medicine, Stanford,...prepare documents for submission as required by the IRB, FDA , OSP and APB requirements, including annual reports, and… more