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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.
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The Executive Director, Regulatory Affairs will develop and execute global regulatory strategic and tactical guidance for the development of innovative new drugs in rare disease ensuring fast to market global product registrations, product promotion, maintenance of products and processes in regulatory compliance with local regulations.
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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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Relevant professional experience includes government, private sector, commercial contracting, or regulatory affairs, international development, international business, or finance with an emphasis on contract and/or grant management cost analysis and pricing, management consulting, or public and/or nonprofit administration.
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The Regulatory Affairs Specialist will provide regulatory support for the Catalent Cell and Gene Therapy sites. This position will evaluate facility change controls for compliance with applicable change control guidance and will maintain site master files and Type V DMFs. In addition, the Regulatory Affairs Specialist will provide audit support and assist in preparing for group meetings and communications as appropriate.
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Assist the Global Inflammation Regulatory Affairs Liaison team with projects to support department goals and objectives. Intern Global Regulatory Affairs, Inflammation. Interns will assist with regulatory submissions and activities, including but not limited to potential submission of clinical study reports, study protocols and protocol amendments, and assist with activities in preparation for DSUR/NDA Annual report/PSUR/PADER.
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This Regulatory Affairs Manager – Digital Health Technology will work on-site at our Alameda, CA location in the Diabetes Care Division. This Regulatory Affairs Manager – Digital Health Technology will provide support for the regulatory department to ensure efficient and compliant business processes and environment.
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We invested in new offices, sector teams and practice groups including higher education; foundations; investor engagement; shareholder activism; governance; regulatory and public affairs, including geopolitical; crisis; litigation; social issues including climate change and diversity, equity and inclusion; cybersecurity, data and privacy; employee engagement; digital communications; opinion research and analysis, and creative services.
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High comfort providing healthcare regulatory advice (Anti-kickback law, FDA, government affairs, antitrust). Ability to work closely with, facilitate interactions within, and influence large cross-functional teams (including representatives from other areas of the law department, regulatory and compliance professionals, and Oncology Ecosystem colleagues.
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Critical Skills: High comfort providing healthcare regulatory advice (Anti-kickback law, FDA, government affairs, antitrust). In June 2022, McKesson and HCA Healthcare announced the creation of a joint venture that will combine McKesson's US Oncology Research (USOR) and HCA Healthcare's Sarah Cannon Research Institute (SCRI.
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This individual will work collaboratively with members of all departments within the company, including but not limited to Offshore Wind Development, Onshore Development, Origination, Transmission, Regulatory, and Environmental Compliance & Strategy.
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Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred) Genmab is looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.
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Executive Director, Advertising & Promotions Regulatory Affairs at Bausch Health in Boise, Idaho, United States Job Description Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurology, Ortho Dermatologics, Medical Aesthetics and Dentistry.
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We invested in new offices, sector teams and practice groups including investor engagement; shareholder activism; governance; regulatory and public affairs, including geopolitical; crisis; litigation; social issues including climate change and diversity, equity and inclusion; cybersecurity, data and privacy; employee engagement; digital communications; opinion research and analysis, and; creative services.
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The Federal Regulatory Affairs Manager will collaborate closely with the North America Team Leader and business-lead Vice Presidents to develop regulatory strategies to ensure registrations are obtained and maintained to meet business objectives and timelines.
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regulatory affairs jobs Company: Ero Locums in WV, District Of Columbia
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