- GRAIL (Menlo Park, CA)
- …products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... and leadership. They may manage and provide direction to regulatory staff and, when required, participate in senior...of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …activities focused in cell therapy. The Associate Director will report to a Senior Director in Regulatory Affairs , Advertising and Promotion. + Review of ... making a positive impact in the cancer field. The Associate Director, Regulatory Affairs , Advertising...day-to-day work. We are creating Kite together, with the recognition that the best teams are built by the… more
- United Therapeutics (Sacramento, CA)
- …or pharma regulatory experience with a Bachelor's Degree in life sciences, quality, regulatory affairs or a related area of study or 10+ years of biologic ... experience with a Master's Degree in life sciences, quality, regulatory affairs or a related area of...Ability to mentor, coach, guide, and train lower to senior level employees **Preferred Qualifications** + Proficient knowledge of… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Collaborate with cross-functional teams, including manufacturing, quality control, and regulatory affairs , to design SAP BRH solutions that optimize ... deep expertise in SAP BRH & SAP QM module, regulatory compliance (such as GxP and FDA), and life...Master's degree or relevant certifications (eg, SAP Certified Application Associate in S/4 HANA and/or SAP BTP) is a… more
- Veterans Affairs, Veterans Health Administration (Loma Linda, CA)
- Summary The Health Systems Specialist in the Office of the Associate Director for Operations reports to a senior member of the Executive Leadership Team (ELT), ... comprised of the highest-ranking senior executives within the healthcare organization. The Health Systems...as Health System Specialist in the Office of the Associate Director for Operations. Incumbent is assigned as direct… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** + This position supports Regulatory Affairs personnel in the coordination, preparation, and submission of all INDs/NDAs/MAAs and life ... submission compliance for Health Authority (HA) acceptance. + Support Regulatory Affairs to deliver high quality and consistent maintenance health authority… more
- City National Bank (Los Angeles, CA)
- …interacting with regulatory agencies, including exam management and other regulatory affairs . * For Banking Compliance related roles, Certified Compliance ... ANALYST* WHAT IS THE OPPORTUNITY? Responsible for working with Associate Director ("AD") to coordinate end-to-end regulatory ...reporting to AD which will be used to inform senior management, Board-level committees and key stakeholders to drive… more
- Gilead Sciences, Inc. (Foster City, CA)
- …will improve the lives of patients with life-threatening illnesses worldwide. The ** Associate Director, Planning, Data & Insights** will be located in Foster City, ... **Data & Analytics Leadership** + Design and implement the Public Affairs measurement and analytics framework. + Build an executive-ready dashboard utilizing… more
- Bristol Myers Squibb (San Diego, CA)
- …(Masters, PhD, PharmD, BSN, etc.) with at least 3+ years of Regulatory Affairs experience in the pharmaceutical industry. **Key Competency Requirements** ... the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies. + Ability to broadly… more
- Edwards Lifesciences (Irvine, CA)
- …and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to ... with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize… more
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