- Gilead Sciences, Inc. (Foster City, CA)
- …the guidance of more senior staff, oversees the preparation of CMC regulatory submissions for investigational and commercial products with solid scientific ... exciting role of Regulatory Affairs Associate II, CMC sits in Gilead's CMC Regulatory...manager support. + Invests in acquiring knowledge about CMC regulatory intelligence including guidelines and … more
- BeOne Medicines (San Mateo, CA)
- …assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. ... the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring...throughout product life cycle. Escalate the critical issues to senior management timely. + Lead or contribute to development… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and improve life by advancing the care of patients with life-threatening diseases. The ** Sr . Clinical Supply Manager ** is a leader that inspires teams while ... Development, Device Development and Clinical Package Engineering, Quality Assurance, Regulatory , Outsourced Manufacturing and Project Management partners to develop… more
- Gilead Sciences, Inc. (Foster City, CA)
- …our team, **Biologics Pre-Pivotal Formulation and Process Development** , as a ** Senior ** **As** **sociate Scientist** . The successful candidate will contribute to ... documentation practices. . Author technical documents such as protocols, reports, regulatory dossier, etc. and prepare data-focused presentations for internal and… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Gilead Sciences, Inc. (Foster City, CA)
- …35 countries worldwide, with headquarters in Foster City, California. ** Senior Director,** **Product Management** **Team** **Lead** **(Early Phase)** **_Location: ... within the broader Pharmaceutical Development and Manufacturing (PDM) organization, the ** Senior Director, Product Management Team Lead** will lead a team of… more
- BeOne Medicines (Emeryville, CA)
- **_General Description:_** Sr . Manager /Associate Director, Supply Chain CMO Management & PM will own and enable the communication, coordinate tasks between the ... production & continuity of supply + Partner with internal stakeholders such as CMC , Regulatory , Quality to ensure on time commercial launch & new market launch… more