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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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ERM specific certification(s), Certified Fraud Examiner (CFE), Certified Regulatory Compliance Manager (CRCM) ERM specific certification(s), Certified Fraud Examiner (CFE), Certified Regulatory Compliance Manager (CRCM.
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Mammoth is hiring a Director/Sr. Director, Regulatory Affairs, Therapeutics, to lead the regulatory activities of our growing CRISPR-based therapeutic programs as we bring them from concept to market.
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You will need to work closely with the Vice President, Global Regulatory Affairs Oncology and Precision Medicine, and collaborate with the biomarker team and global/regional regulatory liaisons to provide Precision Medicine global regulatory guidance.
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Reporting to the Senior Manager of Medicare Regulatory Compliance, the Medicare Regulatory Compliance Specialist will support the oversight and management of the Medicare Compliance Program.
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Cititec Talent has partnered with a boutique commodity trading company who looking to bring a Regulatory Reporting Specialist into the business to lead their regulatory reporting consolidation efforts, as they streamline their regulatory reporting solutions for Dodd-Frank and EMIR compliance.
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Degree RequirementsMinimum BA/BS DegreeExperience RequirementsMinimum of 10+ years Pharmaceutical industry experience prefer knowledge of biotechnology / cell therapy products, including multi-disciplined experience, 8+ years CMC regulatory strategy (biologics/cell therapy experience preferred.
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Develop/implement effective CMC regulatory strategies for global submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks. Provides CMC regulatory guidance to manufacturing and quality teams; evaluates CMC change controls.
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As a member of the Risk & Regulatory Advisory team, you will advise financial institutions on a broad range of credit risk management topics including organization and governance; credit process optimization; risk rating model design, build and implementation; credit regulatory assessments; and Current Expected Credit Losses (CECL) process and tools.
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An Exciting Opportunity at the Nexus of Politics, Energy, Technology, and Sustainability:The Manager of Regulatory Government Relations in Washington, DC USA - Schneider Electric. Schneider Electric has an opportunity for a Manager, Regulatory Government Relations.
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U00A0We are looking for a Director of Regulatory Reporting, a leadership position within the team that is responsible for ensuring the overall integrity of trade and position reporting submitted to the regulators for the Fidelity Broker-Dealers, National Financial and Fidelity Brokerage Services, as well as for correspondent client broker-dealer firms.
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Associate General Counsel- Regulatory and Compliance is a key team member in the Office of the General Counsel reporting to and performing services under the direction of the Senior Vice President and General Counsel for VCU Health System.
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Provide guidance on regulatory requirements, compliance, and best practices for both clinical and non-clinical prior authorization Team Members, IEHP delegates, and contracted vendors. Provide leadership and supervision of day-to-day utilization review functions to ensure high-quality, cost-effective services to Members, IEHP delegates, and vendors to ensure compliance with regulatory requirements, including assisting with current workload when turn-around times may be in jeopardy.
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Maintain clear communication channels with key stakeholders and partners (Development, Safety, Regulatory Affairs, HEOR, Medical Affairs, Precision/Molecular Medicine, and Genetics Research Center) to ensure team resources are focused on critical asset support and related initiatives.
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The Director of State Regulatory Compliance, reporting to the Vice President of Compliance, plays an integral role in the oversight and management of product regulatory compliance activities, for State products offered by MetroPlusHealth including Medicaid, HIV SNP, HARP, CHP, EP, QHP, and Large Group.
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