- Stanford Health Care (Palo Alto, CA)
- …front-line staff, clinic managers, nurse managers, etc.) on medication-related issues such as regulatory changes/compliance, FDA drug recalls, drug ... Clinic Managers and clinic staff on pharmacy-related issues such as regulatory changes/compliance, FDA drug recalls, drug information, special programs,… more
- BeOne Medicines (San Mateo, CA)
- …negotiate with the US FDA as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals of ... the job:** + Uses extensive knowledge of the US FDA regulatory environment and the ability to...in the oncology therapeutic area. + Thorough understanding of drug development process and the pharmaceutical industry and healthcare… more
- Abbott (Santa Clara, CA)
- …of medical device regulations and experience such as from the Food and Drug Administration ( FDA ) Center for Devices and Radiological Health (CDRH). This ... + Communicates with internal groups to share updates on regulatory changes as it pertains to the FDA + Utilizes technical regulatory skills to proposed… more
- Abbott (Santa Clara, CA)
- …and other regulatory requirements. + Complies with US Food and Drug Administration ( FDA ) and international regulations, other regulatory requirements, ... product market entry. **What You'll Work On** + Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve… more
- Ascendis Pharma (Palo Alto, CA)
- …role involves engaging closely with internal peers and externally stakeholders such as the FDA , EMA, and other key regulatory bodies. The candidate must not only ... regulatory affairs strategies + Preferred experience with a drug device combination products + Extensive regulatory ...per year domestically and internationally + Broad experience in Regulatory Affairs, working directly with FDA and… more
- Envista Holdings Corporation (Brea, CA)
- …for authoring department standard operating procedure (SOPs). + Responsible for FDA /Canadian device/ drug establishment registrations and device/ drug listings ... required). + Tracks submissions and maintains electronic and paper regulatory correspondence and approvals (ex: FDA , HC, EU and ROW). + Provide regulatory … more
- Sumitomo Pharma (Sacramento, CA)
- …Manages the planning, tracking, compiling, quality checking and submission of required FDA Submissions (eg Establishment Registrations, Drug Product Listings). + ... and procedures, including computer word processing, electronic document management systems, and regulatory publishing software. + Robust understanding of FDA and… more
- Abbott (Alameda, CA)
- …actions. + Complies with US Food and Drug Administration ( FDA ) and international regulations, other regulatory requirements, Company policies, operating ... levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager - International Compliance Operations** will work...5 of those years related to the preparation of FDA submissions (PMA, IDE, 510(k)) for Class I, II,… more
- Sumitomo Pharma (Sacramento, CA)
- …a working relationship with the Office of Prescription Drug Promotion (OPDP) at FDA . + Serve as internal regulatory expert on FDA regulations, guidance ... a dynamic, highly motivated, and experienced individual for the position of **Director, Regulatory Advertising & Promotion** . The Director is part of the Global … more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- … strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment ... of the drug development process, laws, regulations, and guidelines including FDA , ICH, etc. - Able to successfully interpret and apply regulatory … more