- Gilead Sciences, Inc. (Foster City, CA)
- …with any broader initiatives in this space across the enterprise. + Lead workforce capability design, training strategy , and upskilling initiatives. ... Experience in regulatory operations, strategic planning, and operational execution of CMC RA initiatives. + Experience with CMC requirements for drug… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …of regulatory guidelines and perspective to the cross-functional team. Serve as CMC regulatory lead on global project teams (Pharmaceutical Development, ... Regulatory Strategy ). + Assess and provide regulatory strategy for CMC technical...(NDA/MAA), global submissions, and post-marketing lifecycle management as the CMC Regulatory lead . + … more
- BeOne Medicines (Emeryville, CA)
- …**Essential Functions of the job:** + Lead , develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for ... project + Work collaboratively with cross-functional leads and communicates CMC regulatory strategies for the assigned projects. + Lead regulatory … more
- Gilead Sciences, Inc. (Foster City, CA)
- …. **Global Regulatory Excellence** Lead the development of global CMC regulatory initiatives focused on combination products and devices. Ensure ... with directly relevant professional experience in small molecule and biologics development, global CMC regulatory affairs and CMC technical areas of at… more
- Sumitomo Pharma (Sacramento, CA)
- …in line with the global registration strategy of the product + Supports the global regulatory lead (GRL) and the CMC regulatory lead in ... position may represent GRA in project related meetings, develop regulatory strategy and provide regulatory ...mentoring. **Job Duties and Responsibilities** + As a Regional Regulatory Lead , manage regional (United States, European… more
- Amgen (Thousand Oaks, CA)
- …years of directly related experience **Preferred Qualifications:** + Substantial experience leading CMC /Device Regulatory Affairs strategy and execution for ... to ensure efficient support for submissions and approvals. + Lead cross-functional and global teams on regulatory ...(US, EU, Japan and China) + Knowledge of global CMC /Device regulations and understanding of evolving challenges and health… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- **Position Summary** Provides critical support in developing global regulatory strategy , planning and execution of global investigational and marketed ... lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead . Translates complex pertinent global requirements and provides an… more
- BeOne Medicines (Emeryville, CA)
- …EU, China, APAC, LATAM, etc.). + Serve as a principal advisor to the Global Regulatory Lead (GRL) and Regulatory Regional Leads (RRL), providing strategic ... requirements. + Act as the "COO" to the Global Regulatory Lead , translating strategic regulatory ...propose solutions, and manage critical issues related to global regulatory submissions and strategy . + Oversee preparation… more
- BeOne Medicines (Emeryville, CA)
- …and other international requirements. + Act as the (COO) to the Global Regulatory Lead , translating strategic regulatory vision into actionable project ... impact and adapting strategies accordingly. **Global Project Management Excellence** + Lead and manage complex regulatory submissions (IND/CTA, NDA/BLA/MAA)… more
- AbbVie (Irvine, CA)
- …teams (eg, Global Commercial Team, Global Brand Team, CMC , Integrated evidence strategy team, Value and Access team, Regulatory strategy , etc.). + ... key plan deliverables such as the Integrated Evidence Plan, Regulatory Strategy plans, Brand plans, Operations LRP...multiple assets is also acceptable. + Demonstrated ability to lead . motivate and elicit top performance from teams in… more
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