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Leads and collaborates in the development of post-approval global CMC regulatory strategies for an approved cell and gene therapy product. The Director, Regulatory CMC (Chemistry Manufacturing Controls) is responsible for the development and implementation of post-approval global regulatory CMC strategies for a marketed cell and gene therapy product.
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Lead the development and implementation of global CMC regulatory strategy supporting CGT products. The Senior Director of Regulatory Affairs Chemistry, Manufacturing, and Controls (RCMC) will provide strategic as well as operational leadership of global CMC activities related to Cell & Gene Therapy (GCT) leading to successful registration and life-cycle management of unique and technologically complex products.
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This opportunity will offer you the chance to grow your Regulatory Affairs CMC expertise across a range of disciplines such as nucleic acid therapeutics, lipid-nanoparticle drug delivery, viral delivery systems, and a range of cell therapy products.
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The Sr. Medicare Compliance Program Manager is a key member of the Legal, Regulatory Affairs and Compliance team to support the organizations Medicare Advantage line of business. Advises Medicare Compliance Officer regarding the development and implementation of regulatory strategy, potential areas of regulatory concern, and new government/regulatory developments.
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Cross-functional clinical processes, including data management, biostatistics, medical writing, drug safety/pharmacovigilance, and regulatory affairs. Guides and ensures that the clinical study documentation (documents, images and other digital content) is correctly filed and archived, and that the study is maintained in a trial master file (TMF), so that documentation of GCP compliance is available, if required by a regulatory agency.
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Skilled in writing and supporting the generation of regulatory documents related to Bioanalytical package (e.g. briefing book, assay description, CTD modules for IND/MAA etc) and regulatory interactions (e.g. with FDA CDRH, EU notified bodies.
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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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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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Collaborate with the Project Management and CMC teams and related functions, including discovery, non-clinical development, Formulation, Analytical Development, QA, and CMC Regulatory Affairs. Coordinate/author/review drug substance relevant sections of regulatory documents (IND, IMPD, NDA and MAA.
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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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The Appeals and Grievance Specialist is responsible for managing the resolution process of medical and pharmacy member appeals and/or member generated complaints/grievances, and ensuring compliance with contractual obligations, regulatory requirements and accreditation standards.
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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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5+ years of experience as in-house counsel advising product teams and/or leading regulatory coverage preferably in fintech or institutional financial services. You will partner with innovative product teams harnessing the power of crypto assets and blockchain technology to develop the new financial account for businesses and help plan and implement regulatory strategy against the evolving regulatory landscape for stablecoins and other digital assets.
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Consumer lending product knowledge (e.g., mortgage, auto, credit card), consumer lending life cycle knowledge (e.g., marketing, origination, pricing, risk and servicing), consumer regulation knowledge (e.g., fair lending, CRA, UDAP, TILA, RESPA), regulatory requirements of the Federal Reserve, OCC, OTS and/or FDIC.
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As Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC) Manager, you will be responsible for managing global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects and teams simultaneously.
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regulatory job Title: principal consultant Company: Parexel in Woburn, MA
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