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Reporting to the CEO the SVP/VP Global Regulatory Affairs drives the articulation and. In the short-to-mid term the SVP/VP Global Regulatory Affairs primary focus shall be the. -Experience leading regulatory aspects of late-stage drug development through to market.
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The Manager of Regulatory Affairs at AES Clean Energy (AESCE) will be tasked with supervising AESCE's positions and fostering relationships within the Federal Energy Regulatory Commission (FERC), managing policy positions within Regional and Independent Transmission Organizations (RTO/ISO), and taking the lead on filings and policy positions at state Public Utility Commissions (PUC) or Public Service Commissions (PSC) in key states.
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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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Represent PCDS at team meetings and coordinate between PCDS and other functions including CMC, Regulatory Affairs, Clinical Operations, and Platform and Discovery Sciences. The candidate should possess an in-depth understanding of safety pharmacology, investigative and regulatory toxicology, and have experience designing and critically evaluating results of exploratory and GLP-compliant toxicology studies.
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5+ years of IT risk management, IT audit or regulatory compliance. Maintain and update policies and procedures related to IT and regulatory compliance. 5+ years of IT risk management, IT audit or regulatory compliance.
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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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Collaborate with DOT Compliance department to ensure full regulatory compliance. We are leaders in each of our respective service lines, including Vapor Control, Chemical Cleaning, Tank Cleaning, Water Treatment, Vacuum Services, Hydroblasting, Hydroexcavation, and Industrial Logistics & Transportation.
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Consult with other PIMCO departments on technical tax matters related to product development, product implementation, product distribution, regulatory compliance and ongoing operations. Ability to embrace and adapt to an ever-changing regulatory and technological environment.
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Familiarity with regulatory requirements and compliance in equity capital markets. This is a brand-new role for the firm, reporting to our CO-Chief Investment Officer and will offer an exciting opportunity to become a pivotal partner in shaping our equity capital markets strategy.
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We serve customers in more than 180 countries, operating through four divisions: Health; Tax & Accounting; Governance, Risk & Compliance; and Legal & Regulatory. VP Sales - Enterprise Software (Remote.
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Hands-on experience with Clinical Data Management, including Case Report Form (CRF) design, CRF annotation, database design, data-entry, data validation, discrepancy management, medical coding, data extraction, database locking, and regulatory requirements.
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Identify and collaborate with subject matter experts from other teams, especially Litigation, Regulatory Counsel and Compliance. Manage the intake of contracts for indirect procurement organization, reviewing contracts as necessary and assigning contract review to outside outsourcing vendors and outside counsel.
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Oversee all phases of development, from procurement of the architecture, engineering and construction team to existing conditions assessments, programming, feasibility studies, estimating and budgeting, schematic design through construction documentation, regulatory submissions, bidding, construction, and project close-out.
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Works collaboratively with Senior Leadership Team and staff in meeting HRSA, DPH, NCQA Patient Centered Medical Home recognition and other regulatory and/or funding requirements. Ensures adequate controls are in place and that substantiating documentation is approved and available such that all operating, and capital procurement is compliant with funder and regulatory requirements.
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Regulatory Compliance: Stay abreast of evolving regulatory requirements related to program offerings (Medicare Advantage, ACO REACH, etc), population health management and value-based care, ensuring compliance with relevant laws and regulations.
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regulatory job Company: Aegon Asset Management in Oklahoma, OK
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