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Our client, a growing pharmaceutical company, has engaged GForce to provide a CMC Regulatory Affairs Manager Consultant. Knowledge of CMC regulatory requirements for biologics and small molecules during development and post-approval, including biologic upstream and downstream processes, analytical methods, and drug/device combination products.
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Under the general direction of the Director of Clinical Research, Administration, and Finance of the Center for Clinical Research (CCR), and the Assistant Director of Clinical Research Operations, the Regulatory Affairs Manager (RAM) is responsible for all clinical research regulatory matters in fulfilling the mission of CCR under the University Of California Irvine School Of Medicine and the overall UC Irvine Health enterprise.
Full-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD. Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.
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What we look for: A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD.Demonstrated organizational leadership skills at both functional and enterprise levels.
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15+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs/small molecules.
$113 an hourFull-timeExpandApply NowActive JobUpdated 29 days ago - UpvoteDownvoteShare Job
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The RAM independently directs and supervises the day-to-day management of critical regulatory requirements for clinical research within CCR and has primary responsibility for overseeing regulatory affairs coordinators who are responsible for submitting protocols to clinical research committees [e.g. Institutional Review Board (IRB.
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10+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs and small molecules.
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The Head of CMC Regulatory Affairs / Associate Director will lead the site Regulatory Affairs function and customer related RA CMC compliance activities. Following our agreement with Roche to acquire the Vacaville manufacturing facility, we are now looking to recruit an Associate Director CMC Regulatory Affairs for the Vacaville site.
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External Affairs consists of Communications, Government and Regulatory Affairs, Labor and Workforce Planning, and Community Engagement teams. External Affairs leads Vineyard Offshore’s external presence at the local and state level.
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Our client is looking to fill the role of CMC Regulatory Affairs Manager. Provide CMC regulatory strategy for investigational, new and marketing products (biologics and small molecule focus.
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Work in a dynamic, matrixed environment by collaborating closely with cross-functional teams, including R&D, Regulatory Affairs, Quality Assurance, and project management teams, to ensure regulatory compliance and successful product development.
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CMC regulatory requirement knowledge specifically for biologics and small molecules – development through post approval. 7+ years of CMC regulatory experience in pharma (previous experience with successful.
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CalOptima Health is seeking a highly motivated an experienced Regulatory Affairs & Compliance Analyst to join our team. Under general direction, the Regulatory Affairs and Compliance Analyst for Fraud, Waste and Abuse (FWA) conducts investigations pertaining to allegations of FWA in required timeframes and with appropriate documentation.
$108,824 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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You have experience with US regulatory affairs submissions such as 510(k) and/or PMA. You have at least 10 years of experience in this field so far in your career. You are a seasoned professional in the Regulatory Affairs space with specific experience with IVD and POC products.
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The Senior Director, Regulatory Affairs CMC will be responsible for planning and executing the CMC regulatory strategies for Celldex’s therapeutic development programs. Industry experience of 10 years, of which at least 8 years spent in regulatory affairs with CMC responsibilities.
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regulatory affairs jobs Title: home health rn Company: Enhabit Home Health Hospice in CO, Germany
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