- Gilead Sciences, Inc. (Foster City, CA)
- …teams, including ownership of the nonclinical safety program and contributing to regulatory documents to support drug development candidates across a variety ... in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening… 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
- Fujifilm (Sacramento, CA)
- …in professional organizations. + Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO ... Integration, Customer Service, etc.). + Adheres to the Company's quality and regulatory compliance requirements and ensures that all job duties inherent in the… more
- Fujifilm (Sacramento, CA)
- …to work on customer systems. + Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 ... factors, which may include customer impact, HCUS business priorities, and regulatory requirements. Normally receives little instruction on day-to-day work and… more
- Fujifilm (Sacramento, CA)
- …Klue, Workfront, and others. + Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 ... into actionable user stories and system requirements. + Integrate input from regulatory , marketing, and implementation teams to maintain compliance and accuracy in… 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 ... level of customer satisfaction. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all job duties… more
- AbbVie (Irvine, CA)
- …senior executives + Experience of how different elements (discovery, development, regulatory , commercial etc.) fit together in the drug commercialization ... brands (Development, Discovery, Development Sciences, Operations, Commercial, Market Access, Regulatory , Safety, Project Management, Medical Affairs, etc., and substantial… 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
- Pfizer (South San Francisco, CA)
- …aspects of drug development, also comfortable in discussing commercial and regulatory issues + Management experience - Able to work in a highly complex ... the design, execution and interpretation of studies in support of worldwide regulatory submissions. The individual will be accountable for creating and gaining… more
- AbbVie (South San Francisco, CA)
- …+ Extensive end-to-end (from conception of protocols to successful regulatory submission/approval) oncology and/or hematology drug development experiences ... and collaborative role, the Director works in partnership with clinical and regulatory experts to advance medicines to our patients. Responsibilities: + Lead the… more