- AbbVie (Irvine, CA)
- …required by program needs, in partnership with Discovery, Translational, and CMC colleagues contribute to design and implement translational strategies. May ... strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations and emerging issues.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Development, Device Development and Clinical Package Engineering, Quality Assurance, Regulatory , Outsourced Manufacturing and Project Management partners to develop ... to Quality Assurance and supports the resolution of CAPAs . Partner with Regulatory to ensure labels meet global regulatory requirements and filings accurately… more
- Humana (Sacramento, CA)
- …operates about 340+ senior focused primary care centers in 15 states. The Regulatory Compliance team that supports the PCO is responsibility to assess, investigate, ... areas. In this role, you will serve as a regulatory compliance subject matter expert with the 2nd line...knowledge a plus + Certified Coder (CPC, CRC, and/or CMC ) + Experience with metrics and reporting **Additional Information**… more
- Gilead Sciences, Inc. (Foster City, CA)
- …documentation practices. . Author technical documents such as protocols, reports, regulatory dossier, etc. and prepare data-focused presentations for internal and ... collaboratively on cross-functional teams to support project team strategy and regulatory filings. . Fully embrace a lean-agile mindset, matrix working environment,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …management, clinical labeling, distribution including cold chain, import/export, reverse logistics, CMC and GXP regulations. + Prior experience in complex Oncology ... + Expert knowledge of the FDA GxP standards and regulatory guidance documents such as CFR, Annex 13, EU...as CFR, Annex 13, EU CTR. Able to support regulatory inquiries both face-to-face and with appropriate responses. +… more
- Astrix Technology (San Diego, CA)
- …technical documentation + Perform analytical data review to ensure compliance with regulatory and quality standards + Manage and execute stability studies + Support ... day-to-day operations within the QC department + Report directly to the CMC Expert Manager **Qualifications:** + Master's degree in Chemistry (Bac+5); background in… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and verbal) skills. The ideal candidate would also have: + Experience with CMC requirements for drug development and manufacturing of a range of product modalities. ... the biopharmaceutical industry, R&D, and product commercialization, including the regulatory framework, and of global biopharmaceutical manufacturing sector and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …translational science, biomarker strategy, and early clinical trial design. + Regulatory knowledge: Familiarity with FDA/EMA guidance for preclinical and early ... clinical phases. + CMC awareness: Understanding of drug substance/product development and manufacturing timelines. + Possess strong business acumen to align drug… more
- AECOM (San Diego, CA)
- …(SYSCOMs), Chief of Naval Operations (CNO), Commandant of the Marine Corps ( CMC ), Fleets, and other Navy and Marine Corps commands. + Provide executive-level ... and congressional engagements + Support compliance with legislative and regulatory frameworks related to energy and water resilience initiatives. **DCS-Energy**… more
- University of Southern California (Los Angeles, CA)
- …interactions and activity prioritization. Regularly ensures compliance with all relevant regulatory requirements. + Oversees the implementation of project plans (eg, ... implementation. Develop and review SOPs, protocols and process development reports. Authoring CMC documentation. + Oversee lab setup and work with cGMP facility… more