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Cross-functional Collaboration: Collaborate with cross-functional teams, including clinical development, regulatory affairs, market access, and commercial teams, to align medical affairs activities with clinical trial objectives, regulatory submissions, market access strategies, and commercialization plans.
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Our Regulatory Affairs team is seeking a highly motivated Regulatory Operations Manager. Reporting to the Senior Director of Regulatory Operations, you will be responsible for assembling, formatting, and publishing regulatory dossiers (e.g., IND, CTA, BLA, MAA) for global registration and lifecycle management submissions (e.g., supplements, amendments, variations) to meet corporate objectives for both ongoing business and new product development.
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We’re a leader in staffing Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, HEOR, Market Access, and Sales & Marketing roles. Medical Science Liaison, Hematology/Oncology (Northern CA) TMAC (TMAC Direct) - San Francisco, CA, United States Tagged: MSL, Medical Affairs, Medical Science Liaison, Oncology, Hematology , Field Medical , Pharmaceutical, TMAC Direct Hire Hematology/Oncology MSL Expansion – Top BioPharma CompanyTMAC’s direct-hire service, formerly known as TMAC Direct, is an executive search firm and Pharma’s Complete Recruiting Resource.
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Beyond our offices, clinics, and laboratories within the 107-acre UCSF Parnassus campus above Golden Gate Park, our Department reaches into the Moffitt Long Hospital, the Ambulatory Care Center, the Medical Center at Mount Zion, and shares UCSF’s partnerships with San Francisco General Hospital and the San Francisco Veterans Affairs Medical Center.
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Experience with clinical trials regulatory affairs, or related clinical trials experience such clinical research coordinator experience. Ensure that all investigators maintain the proper credentials and maintain these records in central regulatory binder (e.g. medical licenses, CVs, GCP/HSP certifications, NCI CTEP registration, SIP accounts, etc.
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Degree: community planning; or related field such as urban affairs, architecture, landscape architecture, engineering, sociology, geography, economics, political science, or public administration that included at least 12 semester hours in the planning process, socioeconomic and physical elements of planning, urban and regional economic analysis, and development finance.
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Serve as the main administrative coordinator for the Office of Student Affairs events and work independently to oversee event logistics (including event planning, social media, event promotion, room set-up/clean-up, catering, AV, and IT) and coordinate with departments and offices on main campus and at the law school as needed.
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Responsibilities: Gather information, format, and assemble regulatory submissions, particularly IND Chemistry Manufacturing and Controls (CMC), nonclinical and clinical amendments, as appropriatePerform technical editing (i.e., references, internal/external linking, definitions, acronyms, etc.
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Experience advising on cryptocurrency and blockchain technology legal issues and have a basic understanding of the relevant legal and regulatory landscape; Supporting the business in a wide range of legal coverage areas, including but not limited to token listings, compliance legal support, product promotion and development, global regulatory matters, contract negotiation, and institutional sales and partnerships.
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In collaboration with Quality, Technical Operations, Regulatory Affairs, Clinical Operations, and Finance support automation (Veeva, SAP, logistics), document management (Veeva Vault, Veeva RIMS), and learning management (ComplianceWire) strategies for Kyverna’s operations including qualification, validation, and lifecycle management support.
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Minimum of 8 years of experience in deadline-driven journalism or communications role (such as media relations, public affairs, crisis communications, etc.) Reporting to the Senior Director of Strategic and Crisis Communications ("Director"), the Senior Media Strategist ("Strategist") is responsible for fielding media inquiries; supporting crisis communications responses; and developing communications materials such as press releases, public statements, talking points, and op-eds on behalf of the University and its senior leaders.
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The Programs Division is supported by and works in close coordination with the Department's other divisions: Administration & Finance; Communications & Legislative Affairs; Planning, Performance & Strategy; and the Office of Racial Equity.
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Research, specify, design, verify, and validate very low-power analog front-end design and battery-powered embedded systems per applicable regulatory standards for medical devices. Working experience in EMC/EMI design and testing for regulatory standards.
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Identify, recommend, implement significant and/or complex new electrical design improvements or technologies that meet regulatory requirements. Preferred Skills/Technologies: PCB layout using Altium design tool, EMC design and test (NFC, BLE, Cellular), DFM, DFT, ultra-low power analog design, Agile PLM tool, design requirement management tools such as DOORS and SysML.
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The position offers a high degree of autonomy but is supported by a collaborative team of professionals with expertise in native plants, aquatic and terrestrial ecology, regulatory compliance, fine art/graphics, hydraulics, fluvial geomorphology, and engineering.
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regulatory affairs jobs Title: sr regulatory associate Company: Cardinal Health in Emeryville, CA
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