- Gilead Sciences, Inc. (Foster City, CA)
- …submission and approval process in close partnership with other functions in PDM, Regulatory Affairs , and Clinical Development. + Responsible for development ... and serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director, CMC Regulatory Affairs for Biologics is responsible for defining … more
- Gilead Sciences, Inc. (Foster City, CA)
- …the submission preparation process in close partnership with other functions in PDM, Regulatory Affairs , and Clinical Development. + Exercises expertise in ... degree with directly relevant professional experience in biologics product development, global CMC regulatory affairs , and CMC technical areas of at least 14… more
- Abbott (Alameda, CA)
- …priorities, and to be flexible when priorities change. + Working knowledge of GCP, Clinical and Regulatory Affairs . + Proficient with Microsoft Suite. ... more than 160 countries. **The Opportunity:** The CRA III will assist in the clinical execution and management of all aspects of assigned clinical studies. This… more
- Abbott (Alameda, CA)
- …study site staff, and clinical management. + Working knowledge of CFR, ICH-GCP, Clinical and Regulatory Affairs + Proficient with Microsoft Suite The ... countries. **The Opportunity:** The CRA will ensure quality, accuracy, and integrity of clinical trial data throughout the full lifecycle of multiple clinical … more
- Astrix Technology (Fort Worth, TX)
- ** Regulatory Affairs Specialist** Clinical Fort Worth, TX, US Pay Rate Low: 55 | Pay Rate High: 70 + Added - 30/05/2025 Apply for Job Exciting development ... in the world - with complementary businesses in Surgical and Vision Care. ** Regulatory Affairs Specialist III** **Pay rate: 55.00-70.00 DOE** **1 Year contract… more
- BeOne Medicines (San Mateo, CA)
- …patient communities. **Cross-Functional Collaboration** + Partner closely with R&D, Medical Affairs , Clinical Development, Regulatory , Global Commercial, ... regulatory / compliance frameworks and demonstrating expertise in clinical trials, products' launches and commercialization. The ideal candidate brings an… more
- Boehringer Ingelheim (Ridgefield, CT)
- …pharmaceutical or related industry. + One-plus (1+) years of experience in Medical Affairs , Clinical Trials, Regulatory , or related area supporting relevant ... integrated strategic medical plan and tactics that enable the successful medical affairs contribution to BI's portfolio and informs clinical development efforts… more
- Boehringer Ingelheim (Ridgefield, CT)
- …in pharmaceutical or related industry. *One-plus (1+) years of experience in Medical Affairs , Clinical Trials, Regulatory , or related area supporting ... integrated strategic medical plan and tactics that enable the successful medical affairs contribution to BI's portfolio and informs clinical development efforts… more
- Ascendis Pharma (Palo Alto, CA)
- …serve as a clinical research resource for-cross-functional colleagues (eg in clinical operations, statistics, regulatory affairs , medical affairs , ... regulatory strategy + Contribute to drafting and reviewing of clinical documents, manuscripts, presentations, and regulatory submissions + Maintain… more
- Terumo Neuro (Aliso Viejo, CA)
- …with study timeline and milestones and to provide regular progress updates. + Support clinical science and regulatory affairs functions by utilizing medical ... committees as well as reports of committee findings and results. + Partner with clinical research project managers and Medical Affairs and Safety Manager to… more
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