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The Senior Director, Model Validation for Santander US Compliance models (Transaction Monitoring, Sanctions Screening, Fraud Risk, etc) will be responsible for leading the independent validation of models used by various Compliance groups in conformance with regulatory guidance on model risk SR11-07 and other regulatory requirements around Compliance models.
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Proclinical is seeking a Director, Regulatory Affairs for a mid-sized oncology focused biotechnology company with their site in Massachusetts. Report to our Head of Regulatory Affairs and work side by side with your R&D colleagues to develop and execute innovative regulatory strategies for their development programs (from FIH through late-stage clinical programs), including the implementation of non-clinical and clinical regulatory strategy for relevant products.
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The Global Scientific Affairs COVID & Flu Senior Manager will play a key role in delivering in-house RWE projects and support the development of Vaccines and Antivirals strategy to keep up with the evolving RWE landscape.
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Is accountable for oversight of timely preparation and quality of Preclinical DMPK sections of regulatory documents (IND, NDA, briefing books, Investigator Brochures, etc.) May be a point of contact for government regulatory agencies for their function.
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Experience working with legal counsel on regulatory and legislative affairs. The Virtual Power Plant Policy Director will lead SUN’s policy, regulatory, and advocacy efforts to implement solar + batteries Virtual Power Plant (VPP) policy across the country and in targeted states.
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This individual provides oversight and assistance to Medical Affairs, internal partners, and external vendors to ensure completion of scientific communications projects in an efficient and timely manner that are medically and scientifically accurate and of high editorial quality.
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Investigate and document reports of non-compliance involving laboratory animal care and use, including preparation and submission of reports and other documents to the IACUC, IO, and regulatory and accrediting agencies when indicated.
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Experience managing the entire cell-based assay lifecycle from development, Tech transfer, to commercial and being involved in the BLA/MAA regulatory submissions. Contribute to the preparation and review of CMC (Chemistry, Manufacturing, and Controls) documentation, particularly focusing on the analytical sections required for regulatory filings(BLA/MAA), including post-approval submissions to US and EU regulatory bodies.
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General knowledge of cGMP, GLP, and regulatory requirements for biotech and pharmaceutical industries is highly desirable. Stay current with the latest industry developments and regulatory requirements.
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Our Client's FDA regulatory group works with broad range of companies, including medical devices, drugs, biologics, diagnostics, digital health, research tools, cosmetics, dietary supplements, wellness products, and other consumer products.
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Enforce the rules of the university by working in partnership with the Dean of Student Affairs Office and provide written and oral documentation of violations. The Tufts University Department of Public Safety is comprised of fully sworn and certified police officers, campus security officers, dispatchers, emergency management, fire safety, crisis intervention, threat assessment staff and a student run EMS service.
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Strong knowledge of and/or experience with government programs regulatory, operational, financial, and clinical requirements for the delivery of health insurance and managed care products and services, including Medicare, Medicaid, MMP, LTSS, SNP, Duals, CHIP and behavioral health, as well as the associated and relevant federal, state and local regulatory entities.
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Using an oligonucleotide-based approach, Korro expects to bring its medicines to patients by leveraging its proprietary platform with precedented delivery modalities, manufacturing know-how, and established regulatory pathways of approved oligonucleotide drugs.
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Previous experience in regulatory and legislative processes as they pertain to energy policy, preferably in state-level regulatory advocacy and/or bill negotiation. Synthesize and create actionable research conclusions that provide informed recommendations for regulatory intervention, legislative advocacy, or executive action.
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This includes: an industry-leading dispatch management platform powered by Swoop; comprehensive accident management services; knowledgeable consumer affairs and connected vehicle capabilities; and a growing marketplace of services, discounts and support enabled by a robust partner ecosystem.
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regulatory affairs jobs Title: principal consultant in Cambridge, MA
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