- 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
- 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
- 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
- Gilead Sciences, Inc. (Foster City, CA)
- … strategy, plans and objectives for assigned products or projects. You may act as the Global Regulatory Lead for early-stage or other programs. You will ... and may serve as Regional Regulatory Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission Teams. Provides… 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
- Kelly Services (South San Francisco, CA)
- …Full-time **Location:** Remote (anywhere within the continental US) **Key Responsibilities:** + Lead global regulatory strategy for assigned product(s), ... **Kelly(R) Science & Clinical** is seeking a Vice President/Senior Vice President, Global Regulatory Affairs for a direct-hire position at our late… 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. (Santa Monica, 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
- Bausch + Lomb (Sacramento, CA)
- …to continue leading the advancement of eye health in the future. **Objectives:** Lead and execute global regulatory strategies for development programs ... Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and...key stakeholders, and optimizing business outcomes. **Responsibilities:** + Formulate, lead , and drive integrated regulatory strategies across… 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
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