- Lactalis American Group Inc. (Tulare, CA)
- …for the Sanitation of the plant, ensuring that we meet all the regulatory criteria used to measure cleanliness while still maintaining the department budget. ... net effect, while also maintaining conformance with standards, specifications and regulatory requirements, once approved by QA Manager. + Responsible for… more
- Abbott (Alameda, CA)
- …(GCPs), ICH guidelines, Federal Regulations, department procedures, and other applicable regulatory requirements. + Participate in study start up activities. + ... and final reviews of study data in preparation of regulatory submissions. + May interact with RA/QA in responding...May interact with RA/QA in responding to audits and FDA inquiries. + Perform any other duties as assigned… more
- Gilead Sciences, Inc. (Foster City, CA)
- …input into clinical development documentation, scientific publications and presentations, and regulatory filings. Dependent upon the area of assignment, you may lead ... input into clinical development documentation, scientific publications and presentations and regulatory documentation. + May participate in or lead special projects… more
- ThermoFisher Scientific (San Francisco, CA)
- …Metrics & Trend Reports. Develop and implement Quality Systems aligning with Regulatory and Corporate Standards. Guide team to foster quality culture, compliance, ... trends and have action plans in place to address them. + Support Regulatory Inspections, Corporate Audits, and Client Audits specific to the functions within the… more
- Insight Global (San Diego, CA)
- …management experience (working in a pharmaceutical company with exposure to FDA regulations preferred) * Experience managing technical implementation projects in ... of Veeva and it's support functions including: clinical, quality, safety& regulatory * Experience with ERP * Experience with Microsoft applications technologies… more
- Sutter Health (Oakland, CA)
- …involves a fast-paced environment with an emphasis on compliance and regulatory standards in patient care and medication management. **PHARMACY SERVICES** Assists ... billing, pricing, record keeping, and provision of services required to meet regulatory requirements. Maintains records of drug distribution and works with vendors… more
- Abbott (Milpitas, CA)
- …Interacts internally and externally with executive level management, outside regulatory agencies, customers, vendors and/or suppliers + Coordinates across functional ... and ensures compliance with company policies and procedures (eg compliance with FDA regulations, etc.) + *Makes and executes operational decisions with a strategic… more
- Abbott (Alameda, CA)
- …(GCPs), ICH guidelines, Federal Regulations, department procedures and applicable regulatory requirements. + Responsible for assisting senior staff in planning ... and final reviews of study data in preparation of regulatory submissions. + Involved in the preparation of all...May interact with RA/QA in responding to audits and FDA inquiries. + Perform other function-related activities in addition… more
- Sumitomo Pharma (Sacramento, CA)
- …(ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with cross-functional teams-including clinical ... writing-to maintain the statistical integrity of study conduct. + Support regulatory submissions by preparing responses to agency inquiries and contributing to… more
- Norstella (Sacramento, CA)
- …ensuring the integrity and reliability of insights provided to clients while adhering to regulatory requirements such as HIPAA, GDPR, and FDA RWE guidance. + ... requests into structured queries, ensuring that extracted data aligns with research, regulatory , and business objectives. This role is critical in ensuring our… more