- Stanford University (Stanford, CA)
- …milestones, and invoice sponsors according to study contract. + Ensure regulatory compliance. Regularly inspect study document to ensure ongoing regulatory ... compliance. + Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review… more
- Amgen (Thousand Oaks, CA)
- …technical leadership and oversight of aseptic operations within the multi-product drug product manufacturing facility. This role is accountable for maintaining ... SOPs, reports, and training materials to ensure alignment with current regulatory expectations and site standards. + Partner closely with Quality Assurance,… more
- Stryker (San Jose, CA)
- …+ Partner with cross-functional teams, including marketing, R&D, clinical, regulatory , and operations, to deliver quality, compliant products. + Oversee ... across the software lifecycle by implementing software industry best practices and regulatory standards (FDA, TGA, EUMDR, IT). + Engage in design and development… more
- WSP USA (Irvine, CA)
- …work conforms with specifications, permit applications, compliance documentation, and regulatory and technical analysis memos. + Verify the characteristics of ... implement site Health and Safety Plans (HASPs). + Comply with regulatory requirements pertaining to the data integrity, documentation, procedures, training,… more
- Pfizer (South San Francisco, CA)
- …between the study team, investigators, ethics committees, steering committees, and regulatory authorities. + Lead and contribute to development and maintenance of ... clinical trial and regulatory documents, in collaboration with Clinical Scientist and the...medical leave, and health benefits to include medical, prescription drug , dental and vision coverage. Learn more at Pfizer… more
- Kerry (Commerce, CA)
- …standards, process specifications, formula compliance, sanitation/GMP/pest control, and regulatory compliance.* Ensure that the products released are compliant ... and safe foods.* Be the point person at the site for regulatory inspections (FDA/CFIA), identify preserved (ie, organic, Kosher, HALAL), and customer audits.*… more
- Pfizer (San Diego County, CA)
- …between the study team, investigators, ethics committees, steering committees, and regulatory authorities. + Lead and contribute to development and maintenance of ... clinical trial and regulatory documents, in collaboration with Clinical Scientist and the...medical leave, and health benefits to include medical, prescription drug , dental and vision coverage. Learn more at Pfizer… more
- EchoStar (El Segundo, CA)
- …**Job Duties and Responsibilities** **Key Responsibilities:** + Prepare and file regulatory licensing applications and respond to document requests from government ... skills (a 3-5 page-writing sample required) + Understanding of legal and regulatory language and principles, research methods, and other related matters and… more
- BeOne Medicines (Emeryville, CA)
- …senior leaders in discovery, research, manufacturing, and development on patent, regulatory data exclusivity, trademark, and other intellectual property issues. * ... positions important to BeOne Medicines in matters concerning IP government and regulatory policy. * Conduct patent and prior art search, competitive landscape… more
- Stanford University (Stanford, CA)
- …milestones, and invoice sponsors according to study contract. + Ensure regulatory compliance. Regularly inspect study document to ensure ongoing regulatory ... compliance. + Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review… more