- BeOne Medicines (Emeryville, CA)
- …implementation in multi-institutions and research settings in accordance with FDA regulations and Good Clinical Practice guidelines, tracking and budgeting. ... and non-medical functions (eg, Marketing, Market Access, HEOR, Legal, Compliance, Regulatory , etc.). This position will also assist with program management,… more
- Amgen (Thousand Oaks, CA)
- …that the site meets the quality requirements of its customers and applicable regulations ( FDA , EU & global standards). + Assist in the development of any existing ... continued compliance to the necessary regulations. + Be a key contributor to regulatory filings throughout the authoring, editing and submission process but also be… more
- Fortive Corporation (Irvine, CA)
- …priorities **for facilities and CAPEX investments** , ensuring **compliance with regulatory standards** . + Lead **preventive maintenance programs** to ensure ... improvements and operational excellence** through automation and Lean methodologies. ** Regulatory Compliance & Validation** + Ensure **Building Management Systems… more
- Ascendis Pharma (Palo Alto, CA)
- …of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations. + Ability to ... products be collected, reported, and handled in accordance with global/local regulatory requirements and company policies + Responsible for operational activities of… more
- Deloitte (San Jose, CA)
- …technologies like GenAI, AI/ML, and automation for analytical methods, manufacturing, regulatory and/or QA/QC + Implementation of regulatory authoring tool(s) ... ICH guidelines (ie: ICH Q6A, Q7, Q8, Q9, Q10), FDA /EMA/PMDA regulations, and the structure/content of CMC sections in.../EMA/PMDA regulations, and the structure/content of CMC sections in regulatory submissions (IND, NDA, BLA, MAA) + 1+ years… more
- Terumo Neuro (Aliso Viejo, CA)
- …and to provide regular progress updates. + Support clinical science and regulatory affairs functions by utilizing medical expertise to provide input to study ... evaluation reports, clinical study reports, literature review, risk management, regulatory submissions, questions from regulatory authorities, scientific… more
- University of Southern California (San Diego, CA)
- …Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s). Duties will include but are not limited to: + ... and other monitoring visit activities. + Confirm sites are following GCP, regulatory requirements, study protocol, and ATRI policies. Work with sites to document… more
- ThermoFisher Scientific (San Diego, CA)
- …for storage and testing. Conducts work in compliance with safety and regulatory requirements. May provides supervisory role for junior employees. + Responsible for ... reviews appropriate development reports and stability related sections of regulatory filings, such as INDs, IMPDs, NDAs, etc. +...studies. + Strong knowledge of GMPs, quality systems, and FDA and ICH guidelines, such as ICHQ1. + Highly… more
- Element Materials Technology (Santa Rosa, CA)
- …assistance during cGMP audits conducted at the facility by clients and regulatory agencies + Developing, review and approval of Standard Operating Procedures and ... in chemistry or technical field + cGMP training including FDA and ICH guidelines + Strong oral and written...and fit for purpose. From early R&D, through complex regulatory approvals and into production, our global laboratory network… more
- Veterans Affairs, Veterans Health Administration (Long Beach, CA)
- …care program that meets current Joint Commission, Food and Drug Administration ( FDA ), College of American Pathologists (CAP), NFPA, and VA requirements, particularly ... promoted to the full performance level without further competition when all regulatory , qualification, and performance requirements are met. Selection at a lower… more