- BeOne Medicines (San Mateo, CA)
- …are met while leveraging expedited pathways where appropriate. The individual has regulatory affairs departmental and cross functional influence and acts as ... working experience. + Preferred candidates will have experience working as a lead in Regulatory Affairs across two or more major geographic areas, and prior… more
- Abbott (Santa Clara, CA)
- …device regulations and guidelines, and product and therapeutic area knowledge to support Regulatory Affairs medical device submissions in the EU for CE Marking ... and exchange of documents between stakeholders (eg, internal personnel such as Regulatory Affairs , R&D Engineering, Clinical Engineering, A&P and Marketing,… more
- Bristol Myers Squibb (Brisbane, CA)
- …TM, clinical pharmacology, toxicology, regulatory , HEOR, market access, medical affairs ), applying foresight, scientific and development knowledge to ensure ... than 5 years of extensive clinical trial and drug development experience and regulatory experience, in addition to a strong scientific background, particularly… more
- Merck (South San Francisco, CA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. **Specifically, The Senior Director May… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …including INDs, IBs, clinical study reports, and NDAs/BLAs. + Collaborate with regulatory affairs on interactions with global health authorities. + Provides ... with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director, GCD...programs after proof of concept through late-stage trials and regulatory submissions. + Provide medical and scientific … 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 ... with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize… more
- Danaher Corporation (West Sacramento, CA)
- …many internal and external constituents including physicians and laboratorians, clinical/medical/ scientific affairs , business units, market access, and ... manage lifecycle processes in collaboration with cross-functional teams including R&D and Scientific Affairs . + Identify Market Opportunities & Drive Innovation:… more
- Gilead Sciences, Inc. (Foster City, CA)
- …team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve ... (RWD) to help transform innovations to life-changing medicines for patients. The Senior Director, RWE Inflammation Product Lead reports to the Executive Director,… more
- Merck (South San Francisco, CA)
- …scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations) + ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Global Medical Affairs (GMA), Government Affairs & Policy, Public Affairs and Regulatory Affairs to drive integrated HIV Prevention strategies ... team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve… more