- BD (Becton, Dickinson and Company) (San Diego, CA)
- …communication skills (up, down, and outward) **Preferred Qualifications:** + Experience in Regulatory Affairs preferred. + Experience in metrics, data analytics, ... **Job Description Summary** The Associate Director , Quality Systems & Architecture will be responsible...subject guidance for our Tijuana, Otay, Vienna, and other global sites conducting QMS activities. **Job Description** We are… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …Partner across Kite Medical Affairs , Clinical Development, Translational Medicine, Regulatory Affairs , and Product Teams to build integrated cross-functional ... (IEP) for Kite assets in collaboration with the entire Evidence Generation Function, Global Medical Affairs Strategy and Product Teams. + Provide leadership to… more
- Pfizer (South San Francisco, CA)
- …and external partners, such as project leaders, research units, biostatistics, regulatory affairs , clinical pharmacology, human genetics, translational oncology, ... (POC) studies in Oncology. You will work in close collaboration with the Global Development Lead (GDL)and members of the development team to establish, lead,… more
- BeOne Medicines (San Mateo, CA)
- The Executive Medical Director serves as the Lead Product Safety Physician for multiple or large complex strategically important developmental programs (often ... multi-indication) and creates and maintains a single interpretation of global safety data for developmental and marketed products. With the support of Safety… more
- Gilead Sciences, Inc. (Foster City, CA)
- …digital tools and analytics per our **Quality digital roadmaps** **Compliance & Regulatory Affairs ** + Ensure site-wide compliance with cGMP, FDA, EMA, ... Gilead and help create possible, together. **Job Description** The Senior Director , Quality Assurance leads the site's independent Quality Assurance organization,… more
- Edwards Lifesciences (Irvine, CA)
- …Surgical Structural Heart), and other Business Unit or Corporate functions such as Regulatory Affairs , Compliance, and others. . Reviewing and advising on a ... to work from home as needed.** **How you'll make an impact:** The Manager, Regulatory Counsel reports to the Senior Director , Regulatory Counsel and… more
- Abbott (Temecula, CA)
- …making. + Builds strategic partnerships with internal stakeholders, including operations, regulatory affairs , R&D, clinical, operations QA, and ensures alignment ... Abbott is a global healthcare leader that helps people live more...Interacts internally and externally with executive level management, outside regulatory agencies, customers, vendors and/or suppliers. **Qualifications** + Bachelor's… more
- J&J Family of Companies (Santa Clara, CA)
- … regulatory submissions by analyzing data, interpreting requirements, and supporting the Regulatory Affairs team to ensure compliance with FDA, EU MDR, and ... inspections, ISO certification audits, and MDSAP assessments, with a strong understanding of global regulatory requirements. + Proficiency in 21 CFR Part 820,… more
- Gilead Sciences, Inc. (La Verne, CA)
- …Serve as the site's quality representative to global quality leadership and regulatory agencies. **Compliance & Regulatory Affairs ** + Ensure site-wide ... all Quality functions at the pharmaceutical manufacturing site, ensuring compliance with global regulatory standards, driving a culture of quality and continuous… more
- Sumitomo Pharma (Sacramento, CA)
- …ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + ... Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations...ready for audits and inspections. Partnering with the Associate Director , Clinical Business Operations, the specialist ensures accountable functions… more