- 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 ... + Preferred candidates will have experience working as a lead in Regulatory Affairs across two or more major geographic areas, and prior experience with… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …value and real-world evidence, US and global commercial teams, market access, and regulatory affairs , to ensure integrated global strategies and cohesive medical ... (T0 - T1) or early development (phase 1) assets either within Medical Affairs , Regulatory Affairs , or Clinical Development is preferred. + Minimum of 7+… more
- UCLA Fielding School of Public Health (Los Angeles, CA)
- …and knowledge of FDA regulatory pathways. * ACRP certification, expertise in regulatory affairs and regulatory submissions, IND filings, engagement with ... of FDA regulatory pathways. * ACRP certification, expertise in regulatory affairs and regulatory submissions, IND filings, engagement with the FDA,… 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
- Abbott (Santa Clara, CA)
- …+ Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process. Interacts with regulatory ... + Facilitates communication between Sales and Marketing, R&D, Clinical R&D, Regulatory Affairs , Library Services, Product Performance Group (PPG), Quality… more
- BeOne Medicines (San Mateo, CA)
- …The ideal candidate will have a strong background in research, clinical development, regulatory affairs , and safety, with a particular focus on process ... focus on R&D. + Proven expertise and understanding of research, clinical development, regulatory affairs , and safety processes, workflows and analytics. + Strong… more
- Bausch + Lomb (Sacramento, CA)
- …global team members, other B&L departments (eg, R&D/Project Management, Clinical/Medical Affairs , Biometrics, Regulatory Affairs , Quality Assurance, ... in an accurate and timely manner. + Provide Clinical Operations support to the Regulatory Affairs department. Leadership: + Manage in-house team of CRAs, CTAs… more
- The Brattle Group (San Francisco, CA)
- …consulting firm. We provide expert analysis and testimony in legal disputes, regulatory proceedings, and business strategy. Our teams apply economic, financial, and ... decisions in areas such as corporate finance, energy, competition, and regulatory economics. **WHAT IS ECONOMIC CONSULTING?** Economic consulting involves using… more
- The Brattle Group (San Francisco, CA)
- …consulting firm. We provide expert analysis and testimony in legal disputes, regulatory proceedings, and business strategy. Our teams apply economic, financial, and ... decisions in areas such as corporate finance, energy, competition, and regulatory economics. **WHAT IS ECONOMIC CONSULTING?** Economic consulting involves using… more
- Belcan (Simi Valley, CA)
- …Skills and Knowledge: * Strong knowledge of quality engineering processes and regulatory requirements. * Strong ability to apply a systematic, disciplined, and ... de Revisi*n de Materiales (JRM), que incluye actividades de Causa Ra *z/Acciones Correctivas. * Facilitar actividades de Acciones Correctivas y Preventivas (ACP),… more