- BeOne Medicines (San Mateo, CA)
- **General Description** **_:_** + The Director, Global Regulatory Lead , will be responsible for developing, implementing, and advising on global ... development, regulatory , and registration strategies. + The Director, Global Regulatory Lead supporting programs within BeOne's Hematology Franchise,… more
- BeOne Medicines (Emeryville, CA)
- …regions (US, EU, China, APAC, LATAM, etc.). + Serve as a principal advisor to the Global Regulatory Lead (GRL) and Regulatory Regional Leads (RRL), ... China, and other international requirements. + Act as the "COO" to the Global Regulatory Lead , translating strategic regulatory vision into actionable… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …submissions and manages lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead . Translates complex pertinent global ... submissions and manages lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL). - Identifies the need and obtains … more
- BeOne Medicines (Emeryville, CA)
- …US, EU, China, and other international requirements. + Act as the (COO) to the Global Regulatory Lead , translating strategic regulatory vision into ... **General Description:** The Associate Director, Global Regulatory Project Management (AD, ...strategies accordingly. ** Global Project Management Excellence** + Lead and manage complex regulatory submissions (IND/CTA,… more
- Sumitomo Pharma (Sacramento, CA)
- …project(s) in line with the global registration strategy of the product + Supports the global regulatory lead (GRL) and the CMC regulatory lead ... Affairs (Oncology).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based in...Lead , manage regional (United States, European and/or ROW) regulatory activities as part of a Global … more
- Parexel (Sacramento, CA)
- …across global markets? Parexel is seeking an experienced and highly motivated ** Global Regulatory Labeling Lead ** to provide strategic leadership and ... Label Profile. + Align labeling content and strategy across US, EU, and global regulatory teams; facilitate timely endorsement of labeling decisions by senior… more
- Gilead Sciences, Inc. (Foster City, CA)
- …to align development and regulatory path for combination products and devices. . ** Global Regulatory Excellence** Lead the development of global CMC ... together. **Job Description** . **Strategic Leadership & Vision** Define and drive global regulatory strategies for combination products, ensuring alignment with… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …regulatory guidelines and perspective to the cross-functional team. Serve as CMC regulatory lead on global project teams (Pharmaceutical Development, ... **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is... submissions, and post-marketing lifecycle management as the CMC Regulatory lead . + Regulatory experience… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and capability-building initiatives. + Support inspection readiness and contribute to successful global regulatory submissions. + Lead strategic planning for ... providing expert input on safety strategy, protocol design, and regulatory interactions. + Prepare and lead Safety...to work in matrixed environments + Strong knowledge of global regulatory requirements (FDA, EMA, ICH, etc.).… more
- Terumo Neuro (Aliso Viejo, CA)
- …and contribute into developing, editing, or revising regulatory processes. + Lead training for global regulatory processes and system implementations. ... partner with the cross functions on the team to ensure alignment of global regulatory strategy with the team objectives. + Identify regulatory requirements… more