- 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...is a plus. + Demonstrated leadership as a people manager . + Experience in authoring complex technical documents, CTD… more
- Deloitte (San Jose, CA)
- …(ie: ICH Q6A, Q7, Q8, Q9, Q10), FDA/EMA/PMDA regulations, and the structure/content of CMC sections in regulatory submissions (IND, NDA, BLA, MAA) + 1+ years ... equitable future of health. Work You'll Do As a Manager you will lead and deliver engagements, or components...+ 4+ years Life Sciences Chemistry, Manufacturing, and Controls ( CMC ) experience to include: + Introducing new technologies like… 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
- Deloitte (Los Angeles, CA)
- …health Recruiting for this role ends on 8/31/2025 Work You'll Do As a Manager you will lead and deliver engagements, or components of large, complex engagements. ... experience + 4+ years of experience in Life Sciences Pharmaceutical R&D regulatory domain. Experience to include: introducing new technologies like GenAI, AI/ML, and… more
- Vera Therapeutics (Brisbane, CA)
- …assessment of process capabilities. * Prepare, review, or edit cGMP batch records, CMC regulatory and quality documents. * Participate in vendor selection ... Title: Senior Manager , Manufacturing, Drug Product Location: Remote About Us:...addition, the role requires authoring, reviewing, and editing of CMC related regulatory submissions and associated quality… more
- Gilead Sciences, Inc. (Foster City, CA)
- …the care of patients with life-threatening diseases. The **Sr. Clinical Supply Manager ** is a leader that inspires teams while providing expertise for Gilead's ... Development, Device Development and Clinical Package Engineering, Quality Assurance, Regulatory , Outsourced Manufacturing and Project Management partners to develop… more
- BeOne Medicines (Emeryville, CA)
- …cost-effective production & continuity of supply + Partner with internal stakeholders such as CMC , Regulatory , Quality to ensure on time commercial launch & new ... **_General Description:_** Sr. Manager /Associate Director, Supply Chain CMO Management & PM...a scientific field. Minimum 10 years' experience within biopharmaceutical/pharmaceutical CMC development, GMP and regulatory requirements **Computer… more
- Vera Therapeutics (Brisbane, CA)
- …with a strong focus on vendor selection and performance management, regulatory compliance, risk mitigation, contract oversight & management and operational ... excellence. Critical partners for these activities include CMC & Clinical Operations. This person will oversee clinical and commercial supply chains, ensuring… more
- Gilead Sciences, Inc. (Foster City, CA)
- …documentation practices. . Author technical documents such as protocols, reports, regulatory dossier, etc. and prepare data-focused presentations for internal and ... in project meetings. . Analyze data and draft conclusions before discussing with manager or supervisor. . Support or represent function and work collaboratively on… more
- Astrix Technology (San Diego, CA)
- …and day-to-day operations within the QC department + Report directly to the CMC Expert Manager **Qualifications:** + Master's degree in Chemistry (Bac+5); ... technical documentation + Perform analytical data review to ensure compliance with regulatory and quality standards + Manage and execute stability studies + Support… more
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