- Sumitomo Pharma (Sacramento, CA)
- …goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, to secure trial approvals and ... Regulatory Interactions: + Prepare and present clinical data to regulatory agencies ( FDA , EMA) during IND submissions, clinical study reports, and NDA/MAA filings. +… more
- Cardinal Health (Sacramento, CA)
- …to update manufacturer knowledge such as IPD Analytics, Evaluate Pharma, IQVIA, Medi-Span, FDA Orange and Purple Books, and more. + Conduct secondary research (eg, ... industry knowledge, and report generation. + Understand brand-to-biosimilars conversions, FDA regulatory dynamics (eg, drug application submissions and approvals),… more
- Merck (Sacramento, CA)
- …response to product inquiries and adverse reports in accordance with internal, FDA , CFIA and USDA regulatory policies. The successful candidate for this position ... Cattle, Biopharmaceuticals, Cattle Feeding, Cattle Production, Customer-Focused, Data Analysis, FDA Regulations, Feedlots, Field Sales Support, Livestock Management, Nutritional… more
- Abbott (Pleasanton, CA)
- …Control Plans. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, company policies, operating procedures, processes, ... experience and demonstrated use of Quality tools/methodologies + Detailed knowledge of FDA , GMP, ISO 13485, and ISO 14971 + Solid communication and interpersonal… more
- Astrix Technology (San Bernardino, CA)
- …food industry. + In-depth knowledge of food safety programs and compliance ( FDA , USDA, HACCP, GMP, Allergen Programs). + Understanding of labeling regulations ... including FDA , COOL, Prop 65, nutritional warnings, and health claims. + Experience using **ESHA Genesis** for NLEA labeling and nutritional data development. +… more
- Lactalis American Group Inc. (Tulare, CA)
- …System). + Ensure all maintenance work is performed in compliance with OSHA, FDA , USDA, and other applicable regulations. + Manage spare parts inventory, work with ... + Working knowledge of regulatory requirements in dairy/food manufacturing ( FDA , USDA, OSHA). + Excellent troubleshooting, analytical, and problem-solving skills.… more
- United Therapeutics (Sacramento, CA)
- …daughter's pulmonary arterial hypertension( **PAH)** . Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... train lower to senior level employees **Preferred Qualifications** + Proficient knowledge of FDA regulations, including 21 CFR 1271 and 21 CFR 312 **Job Location**… more
- Terumo Neuro (Aliso Viejo, CA)
- …submission activities focused on US/EU/Canada and ensuring compliance to FDA and international regulatory agency requirements for Neurovascular and Peripheral ... regulatory experience. 3. Strong technical writing skills as evidence by successful US FDA Class II / III medical device submissions, EU CE Mark applications, Health… more
- Vera Therapeutics (Brisbane, CA)
- …will oversee clinical and commercial supply chains, ensuring alignment with FDA /EMA standards, cold chain logistics protocols, and enterprise-wide risk management ... cost sheets, etc. Compliance & Regulatory Oversight * Ensure full compliance with FDA , EMA, GMP, GCP, GDP, and SOX regulations across all supply chain activities,… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- **Job Description Summary** Fulfill FDA , ISO and other relevant requirements for designated complaint handling unit, and evaluation of events for reportability to ... for Medical Device Reporting (MDR) + Prepare and submit MDR reports to FDA + Identify problems and lead projects to improve processes, procedures, and/or practices;… more