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Bachelor's degree or equivalent in a life science and 8+ years of experience in regulatory affairs in the pharmaceutical/biotech industry. Individual must have prior project regulatory leadership experience with specific focus on the CMC aspects for small molecules, large molecules and/or gene therapies, including detailed knowledge of FDA and EMA regulations and guidance for drug development, preparation and management of IND/CTA/MAA/NDA/BLA. Prior experience with preparation and preferably, negotiation to marketing approval in major markets is desirable OR.
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The department is part of the Vice President for Student Affairs and Campus Diversity/Dean of Students sub-division. Position upholds the Student Affairs and Campus Diversity Statement on Diversity, Equity, and Inclusion, specifically: “The Division of Student Affairs and Campus Diversity acknowledges and honors the inherent value and dignity of all individuals by creating and nurturing a learning and working environment that affirms and leverages our community’s diversity of traditions, heritages, perspectives, and experiences.
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Department SummaryThe Office of the Vice President for Student Affairs and Campus Diversity is responsible for the coordination and development of student services and building the inclusive excellence of SDSU's staff and faculty at San Diego State University.
$3,764 - $4,604 a month(student)ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Assistant Engineer - Mechanical employees who do not have a valid State of California Professional Engineer registration but have a valid Engineer-in-Training (EIT) certification that meets the requirements established by California's Department of Consumer Affairs, Board for Professional Engineers, Land Surveyors, and Geologists are eligible for 8% additional pay.
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The Division of Student Affairs and Campus Diversity acknowledges and honors the inherent value and dignity of all individuals by creating and nurturing a learning and working environment that affirms and leverages our community's diversity of traditions, heritages, perspectives, and experiences.
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Maintain working knowledge of the policies and procedures of the Human Research Protections Program HRPP and of the VA Human Subjects Office review these policies and procedures under the general supervision of the Medical Director of Regulatory Affairs and as needed, consult with HRPP analysts and the CTO Quality Assurance Manager to resolve issues.
$34 - $55 an hourExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Managing Editor leads a team of editors who supervise reporters with beats including but not limited to metro, military and veterans affairs, science and technology, democracy, homelessness, cost of living, racial justice and social equity, arts & culture, health, environment and education.
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Coordinates with project manager, discipline leads, inter-discipline teams, high value engineering centers, clients, regulatory entities, vendors and sub-contractors; Develops/Reviews Stormwater Management Reports and Stormwater Pollution Prevention Plans (SWPPP) to support regulatory permits.
$93,400 - $155,100 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Program Manager will partner with leads in Marketing, Clinical and Regulatory Affairs, Exact Sciences Laboratories, Technical Services, and Operations, among others to ensure cross-functional coordination and timely delivery of new products.
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Works with the Director, Deposit Operations to fulfil required IRA/HSA regulatory notices and changes to regulatory rules. · In conjunction with Compliance and the Director, Deposit Operations, monitors Fiduciary and Death Claim settlement regulatory rules.
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Maintains and meets expectations on time for all competencies, license, certifications and education requirements as outlined by local administration, Adventist Health (AH), The Joint Commission (TJC), Centers for Medicare and Medicaid Services (CMS), and all other regulatory agencies.
$1,876.53 - $2,068.02 a weekFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Strong business and industry regulatory acumen complemented by claims adjusting knowledge, premium and medical billing familiarity, and industry best practices in risk management and fraud detection/prevention.
$148,760 - $190,370 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The noise level in the outdoor shipyard production environment is moderate to noisy 70% of time which may include sirens, horns, chipping, and hammering ACCOUNTABILITY Ensures NASSCO’s Injury and Illness Prevention Program meets company and regulatory requirements and is effectively implemented.
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Familiarity with SSAE, HITRUST, federal/state, HIPAA, PCI and regulatory requirements for information security. Assists in the establishment of a security strategy program to include determining appropriate policy to meet regulatory compliance, risk identification and mitigation, security architecture and necessary infrastructure of the enterprise.
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Assisting in marketing business opportunities with key clients and development of responses to RFP/RFQs. Developing long term relationships with clients Assisting clients with permitting Successfully interfacing with multi-disciplinary design teams, including civil site design, structural, surveying, and geotechnical engineering Mentoring junior engineers Presentations to governing boards and city councils Work with local and state regulatory agencies for project permitting, funding, etc.
$135,000 - $150,000 a yearFull-timeExpandApply NowActive JobUpdated Today
regulatory affairs jobs Title: senior manager in San Diego, Beech-grove, Indiana
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