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May oversee and direct the work of other Regulatory Affairs professionals. Serves as a regulatory liaison for new product development and make regulatory assessments of proposed changes to existing products for impact to regulatory documentation.
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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.
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Fiscal Year 2023-2024 Position Title Academic Advisor, SAAP Academic Affairs Classification Title Academic Advisor Department SAAP Academic Affairs Posting Number P240089 Posting Link Employer State Position Type Professional Appointment Term Term Salary Grade SL3.
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Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Specialist will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events.
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Communicates with involved campus entities, such as the Deans of Student Affairs, the AVP of Academic Affairs and BETA and CARE Team. Ensures continuity of care for students is also being managed through these entities in accordance with Maryland Mental Health Code and professional ethical standards.
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The Army public affairs specialist participates in and assists with the supervision and administration of Army public affairs programs primarily through news releases, newspaper articles, Web-based material and photographs for use in military and civilian news media.
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Position Title: Academic Advisor, SAAP Academic Affairs Posting Number: P240089 Employer: State Salary Range: $53,151 FTE: 1.00 Position Summary: The School of Architecture and Planning ( at the University at Buffalo - The State University of New York invites applications for an Academic Advisor.
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Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Regulatory Affairs Specialist. The Senior Regulatory Affairs Specialist will be responsible for developing strategies to obtain FDA clearance or approval of new Class II & III cardiovascular medical devices and improvements to existing devices.
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The Office of Academic Affairs, Student Counseling Center (SCC)*is recruiting for a*temporary contractual (Contingent Category I/CI) Academic Affairs - Counseling Center. Experience:*None. *Supervisory Experience:*N/A. *Certification/Licensure: *Licensed Master Social Work - (LMSW) or Licensed Graduate Professional Counselor - (LGPC) in the State of Maryland.
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Be passionate about Regulatory Affairs impact in support of the research, development, clinical, marketing, and production of state-of-the-art class III cardiovascular medical devices. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.
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The Deputy Chief of Staff advises, collaborates, and works closely with senior UW leadership on behalf of the President and Provost to advance the University's mission and ensure strategic alignment within Academic Affairs functions.
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AURORA UNIVERSITY PROVOST AND EXECUTIVE VICE PRESIDENT FOR ACADEMIC AFFAIRS Aurora University (AU), a private university located in Aurora, Illinois, invites nominations and applications for the position of Provost and Executive Vice President for Academic Affairs (Provost.
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Minimum of 10 years of biotechnology/pharmaceutical/medical device industry experience in medical affairs, medical technology, medical strategy with experience in all phases for development projects and regulatory space or combination of relevant clinical practice, training, and education.
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Two years post-masters experiences working in fraternity & sorority affairs, housing or residence life. Knowledge of and a working understanding of current best practices in Fraternity and Sorority Affairs, health and safety practices and the structure of NIC, NPHC, MGC and NPC organizations.
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Regulatory affairs experience in the medical device industry with a track record of successful submissions. Experience in reviews of engineering, manufacturing, marketing, labeling and clinical documents for regulatory compliance.
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affairs job Title: regulatory affairs specialist Company: Amgen
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