- Abbott (Pleasanton, CA)
- …function as a Core Team Member) + Complies with US Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating ... procedures, processes, and task assignments. + Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. **Required Qualifications** + AssociatesDegree . + Minimum 1 year experience.… more
- Abbott (San Jose, CA)
- …appointments, and making travel plans. + Complies with US Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, ... operating procedures, processes, and task assignments. + Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. + Interacts with customers and assigned institutions, physicians and… more
- Fujifilm (Sacramento, CA)
- …established policies and procedures. + Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO ... variable factors which may include customer impact, HCUS business priorities and regulatory requirements. Provides to assistance to all connected teams on technical… more
- Amgen (Thousand Oaks, CA)
- …Let's change the world! As part of Amgen's Process Development organization, Drug Product Technologies (DPT) is seeking a highly motivated **Senior Engineer** to ... role in bringing a wide variety of high-quality clinical and licensed drug products to patients through demonstrated excellence in aseptic processing, technology… more
- AbbVie (Irvine, CA)
- …development strategy for the late-stage assets, aligning with the clinical and regulatory development strategy from the Asset Strategy Team (AST). The programs can ... small molecules, biologics (protein, gene therapy, toxin etc) and antibody drug conjugates. Product presentations can include oral dose, parentals and devices… more
- Lilly (San Diego, CA)
- …products, new and updated labels, grant submissions and contracts, contacts with regulatory and other governmental agencies; and the outreach activities aimed at the ... of clinical compounds, focusing on studies required for product decision or regulatory submission. + Support preparation of high-level plan for phase 1, 2… more
- Fujifilm (Sacramento, CA)
- …established policies and procedures. + Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO ... to work on customer systems. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all job duties inherent… more
- BeOne Medicines (Emeryville, CA)
- …signals, evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory -required periodic reporting. Physicians in this ... committees. + Lead the authoring and review of safety sections of regulatory submissions, eg, IND/CTA (General Investigational Plans, China Risk Control Plans),… more
- Sumitomo Pharma (Sacramento, CA)
- …programs, and liaises with Clinical (including Clinical Operations), Biometrics, Regulatory , Early Clinical Development, Pre-clinical research, Medical Affairs and ... oversee clinical trial strategies, ensuring alignment with corporate objectives and regulatory requirements for SMPA and the future oncology initiatives. + Medical… more
- Rincon Consultants (San Luis Obispo, CA)
- …This includes close collaboration with peers, junior staff, clients, and regulatory agencies on complex, multi-disciplinary efforts. This position is ideally based ... technical studies and QA/QC of biological resource reports, CEQA/NEPA analyses, and regulatory permit applications with a focus on aquatic species and habitats +… more