- Takeda Pharmaceuticals (Los Angeles, CA)
- …of Microbiology methodologies, analyzing complex data, and ensuring compliance with regulatory standards. Self-led individual that works under only very general ... assessments for QC Microbiology to align with Global standards and regulatory requirements. + Maintain applicable QC Microbiology Standard Operating Procedures (SOP)… more
- NBC Universal (Universal City, CA)
- …and adherence to food safety, sanitation standards, corporate QA procedures, and regulatory requirements. + Serve as a proactive and reactive liaison with ... regulatory authorities, maintaining current knowledge of applicable and forthcoming...to specific projects and events. + Stay informed on regulatory agency updates regarding emerging concerns, consumer advisories, food… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and platform operations, and partners closely with Biostatistics, Clinical Operations, Regulatory , and Quality to ensure compliant, efficient, and scalable delivery. ... to deliver high-quality statistical programming solutions for clinical trials and regulatory submissions. + Set clear goals, conduct performance assessments, and… more
- Meta (Menlo Park, CA)
- …of Meta's security risk management and compliance across multiple business units, regulatory entities, and governance forums. As a senior individual contributor, you ... Legal, and deliver meaningful impact on Meta's ability to meet global regulatory requirements and business objectives. You will operate with significant autonomy,… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …design, implementation, and governance of global learning strategies that support regulatory readiness, operational excellence, and a strong quality culture. **Key ... Define and execute the global GxP training strategy in alignment with regulatory requirements and corporate quality objectives. + Establish governance frameworks for… more
- Genentech (South San Francisco, CA)
- …with agility and scientific depth, supporting exploratory analyses, early regulatory engagements, and complex data-generation needs across therapeutic areas. ... complex, often high-dimensional data to inform early go/no-go decisions and regulatory interactions. The Statistician helps shape the early clinical narrative by… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …to drive alignment of labeling content and strategy. + Partner with Global Regulatory Affairs to ensure that all labeling is aligned with the product global ... all global labeling components. + Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate. + Collaborate with global… more
- Genentech (South San Francisco, CA)
- …This role requires strong cross-functional collaboration to ensure alignment across regulatory , biomarker, safety, and commercial functions. The GDL also contributes ... and input; you will take a lead role with other CST members, regulatory and other internal partners/stakeholders in the completion and submission of regulatory… more
- Edwards Lifesciences (Sacramento, CA)
- …with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize ... trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements. + Leading in the development of technical training on GCPs,… more
- Cytel (Sacramento, CA)
- …complex consulting engagements, and guide clients in shaping optimal regulatory and clinical development pathways. **Strategic Consulting & Thought Leadership** ... in Quantitative Clinical Pharmacology, Pop-PK/PK-PD modeling, MIDD, and quantitative regulatory strategies. + Lead the development and dissemination of innovative… more