- BD (Becton, Dickinson and Company) (San Diego, CA)
- …your best self. Become a maker of _possible_ with us. The Director of Regulatory Affairs reports directly to the Senior Director of Regulatory Affairs. This ... Software and Accessories on a global basis from a Regulatory Affairs standpoint. Support will consist of new product...other science related discipline + Advanced degree (eg MS, PhD ) preferred + RAPS RAC certification preferred + Minimum… more
- Lilly (San Diego, CA)
- …test therapeutic hypotheses + Collaborate with clinical pharmacology, biostatistics, regulatory affairs, operations, and other stakeholders to optimize study design ... early clinical studies and enable early decision-making + Contribute to regulatory interactions, including pre-IND, IND submissions, interactions to ex-US health… more
- Gilead Sciences, Inc. (Oceanside, CA)
- …and regulatory awareness across the organization. **Basic Qualifications:** + PhD with 8+ years of relevant experience in the pharmaceutical industry OR ... long-term career development. The Director ensures compliance with global regulatory requirements, marketing authorization holder expectations, and internal quality… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …aspects-from concept through to commercialization-with a sharp focus on scientific rigor and regulatory compliance. This new role is ideal for someone who thrives in ... product characterization, verification and validation activities, as well as the regulatory landscapes that guide these activities. By working successfully across… more
- Amazon (Los Gatos, CA)
- …join us in shaping the future of the connected home. As Manager of Regulatory Compliance, Safety, and RF Validation Engineering, you will lead a team of individual ... and ensuring eero's product portfolio meets internal specifications and regulatory compliance. This role combines strategic leadership with hands-on technical… more
- Gilead Sciences, Inc. (Foster City, CA)
- …ideal candidate will possess deep expertise in SAP BRH & SAP QM module, regulatory compliance (such as GxP and FDA), and life sciences Quality Management and Batch ... solutions that can adapt to evolving business requirements and regulatory landscapes. + Conduct detailed gap analyses and propose...+ Master's Degree and 6 Years' Experience OR + PhD + 8+ years of experience with SAP, specifically… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …The role also requires a strong emphasis on viral safety and regulatory compliance. The successful candidate will bring deep technical expertise and leadership ... workflows, and ensure viral safety strategies are aligned with global regulatory expectations. The Director will operate strategically in a highly collaborative… more
- BeOne Medicines (San Mateo, CA)
- …evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory -required periodic reporting._ _Physicians in this ... Lead the authoring and review of safety sections of regulatory submissions, eg, IND/CTA (General Investigational Plans, China Risk...and PowerBI **Other Qualifications:** + PharmD, NP, RN, or PhD in a medical field or biological science and… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …for promotional and educational materials, clinical trial protocols, and regulatory submissions. + Establish and maintain appropriate scientific interactions with ... clinical trial data and communicate findings to internal teams, regulatory bodies, and scientific communities. **Cross-Functional Collaboration:** + Partner closely… more
- BeOne Medicines (San Carlos, CA)
- …design, proficiency testing, and analytical/clinical validation, ensuring readiness for regulatory and clinical decision points. + Direct the comprehensive analysis ... to enhance biomarker discovery and development efforts. + Contribute to regulatory submissions related to biomarker strategies and companion diagnostics. + Champion… more