- Sumitomo Pharma (Sacramento, CA)
- …encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and ... and manages Safety Charters + Handles Health Hazard Evaluations and Ad-Hoc Regulatory safety inquiries. + Represents PVRM on post-marketing product specific and/or… more
- Stryker (Irvine, CA)
- …to enhance quality performance across the business and for customers while ensuring regulatory standards and compliance . **What You Will Do:** + Work closely ... + Medical device industry experience is strongly preferred. + Experience in interacting with regulatory agencies ( FDA , MoH, TUV, etc.). + Understanding of US and… more
- Sumitomo Pharma (Sacramento, CA)
- …Integrated Summary of Efficacy (ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with ... Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations is a plus...considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and… more
- University of Southern California (Los Angeles, CA)
- …particulate monitoring and surface sampling). Follows established SOPs and adheres to regulatory guidelines, ensuring compliance with cGMP and safety protocols. ... to troubleshoot and resolve technical issues in a timely manner. Knowledge of regulatory requirements and guidelines (eg, FDA , EMA) related to cGMP. REQ20165292… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and reviews routine regulatory documents to ensure that CROs are in compliance with protocols, regulatory requirements, SOPs, and monitoring plans. + May be ... trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports… more
- Amgen (Thousand Oaks, CA)
- …pre-clinical toxicology approaches + Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory ... range of audiences, including executive leadership, development partners, and global regulatory agencies. This role will include global development leadership of one… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …potentially formulation/fill-finish operations. + Experience with cGMP manufacturing environments and regulatory requirements ( FDA , EMA, ICH). + Familiarity with ... This role is responsible for ensuring the robustness, scalability, and compliance of downstream operations through effective technology transfer, validation support,… more
- Abbott (Pleasanton, CA)
- …Assurance: Ensure all test strategies and practices align with medical device regulatory standards ( FDA , ISO, IEC 62304).Support documentation, verification, and ... will collaborate cross-functionally with development, product, operations, quality, and regulatory teams to ensure the delivery of high-quality, compliant software… more
- Abbott (Sylmar, CA)
- …method validation activities. + Ensure DHF content completion, integrity, and regulatory & standards compliance ; collaboratively communicating & resolving gaps. ... requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures,… more
- J&J Family of Companies (Irvine, CA)
- …multiple cross-functional partners including Marketing, Medical Affairs, Clinical Teams, Regulatory Affairs, and Sales Leadership. Your leadership will drive the ... AR/VR, Telementoring, + Maintain the required training documents that fulfill the FDA training commitment for TRUFILL n-BCA Liquid Embolic System and Enterprise… more