- Taiho Oncology (Pleasanton, CA)
- Sr . Director , Regulatory Affairs Strategy...Japan and Asia. For assigned projects and products, the Senior Director , Regulatory Affairs ... and Europe. Position Summary: The incumbent is the most senior regulatory person on project teams and...and contractors. Performance Objectives: + Responsible to represent the Regulatory Affairs position and decision in assigned… more
- BeiGene (Emeryville, CA)
- **General Description** + The Senior Director , Global Regulatory Lead will be responsible for developing, implementing, and advising on global regulatory ... are met while leveraging expedited pathways where appropriate. The individual has regulatory affairs departmental and cross-functional influence and acts as an… more
- BeiGene (Emeryville, CA)
- **Position Summary:** The Senior Director is responsible for setting the vision and mission for the Global Regulatory Operations &GRA Excellence function. ... best practice submission processes. The SD will successfully lead the Global Regulatory Affairs organization in identifying and guiding process optimization and… more
- Sutter Health (Emeryville, CA)
- …and procedures Ensures complete and accurate GMEC membership Strategy/Planning Works with the Sr . Director , Academic Affairs to support and execute the ... + Demonstrated knowledge of clinical research concepts, good clinical practices and regulatory compliance. + Proficient with Microsoft Word, PowerPoint and Excel. +… more
- BeiGene (Emeryville, CA)
- …are met while leveraging expedited pathways where appropriate.** **The individual has regulatory affairs departmental and cross-functional influence and acts as ... **General** **Description** **_:_** **The Executive Director , Global Regulatory Portfolio Lead will...candidates will have experience working as a lead in Regulatory Affairs across two or more major… more
- BeiGene (Emeryville, CA)
- …are met while leveraging expedited pathways where appropriate. The individual has regulatory affairs departmental and cross functional influence and acts as ... **General Description** **_:_** + The Director , Global Regulatory Lead, will be...candidates will have experience working as a lead in Regulatory Affairs across two or more major… more
- BeiGene (Emeryville, CA)
- …**Working knowledge of drug/biologics development, clinical research, study design, biostatistics, and regulatory affairs (eg, FDA and ICH guidelines for various ... **General Description:** **Responsible for leading clinical regulatory medical writing activities for BeiGene that conform to domestic and/or international … more
- BeiGene (Emeryville, CA)
- …position will have oversight for supporting functional areas such as Regulatory Affairs (CMC, Strategy, Project Management), Quality/Manufacturing, Clinical, and ... work. + Serve as a primary lead on global programs within R&D and Global Regulatory Affairs , including the ability to lead both strategy, program management and… more
- BeiGene (Emeryville, CA)
- …and collaboration with functional area peers including Drug Safety, Quality Assurance and Regulatory Affairs , as well as thought leaders in order to meet ... The Associate Director (AD) Clinical Study Management leads both indirect...contracts and/or work order changes prior to submission to senior management for approval. The AD CSM establishes and… more
- Abbott (Pleasanton, CA)
- …and cross-functional teams. This FCS position works closely with Global Clinical Affairs (GCA) including the Medical Director and Program Management, Global ... generic medicines. Our 114,000 colleagues serve people in more than 160 countries. ** Senior Field Clinical Specialist** **Working at Abbott** At Abbott, you can do… more