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Position Details: Position Type: Associate Principal Scientist (Regulatory)Job Location: West Point, PA (Hybrid)Benefits: K, Dental insurance, Life Insurance, Medical Insurance, Vision InsuranceDuration: Year DescriptionThe individual will support teams on the development, validation, analysis, and interpretation of endpoints to support regulatory submissions, reimbursement evidence dossiers, payer interactions, and publications.
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Counsel and advise the BU in areas of product safety (including TSCA, FIFRA, FDA, OSHA Hazard Communication, Hazardous Materials Transportation), product regulatory affairs, product stewardship, and product risk management as such areas may impact the research, development, manufacture, marketing, sale, handling, transportation and advertising of the BU(s) products.
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The Regulatory Program Manager (RPM) will be an asset-level operational leader, driving projects forward through the translation and distillation of overall global regulatory strategy to executable plans and the coordination of cross-functional team efforts.
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Mentors and provides oversight to junior department members supporting Commercial Regulatory Affairs activities. Ensures compliance with all FDA regulations for prescription drug, advertising, and promotions, provides regulatory guidance for the development, review, approval, and implementation of promotional materials and other related activities with an increased level of independence.
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Deep competency in developing optimal regulatory strategy globally and understanding of regulatory requirements throughout the development spectrum (preclinical to post-marketing). M.D. or PhD with 7-12 years relevant drug development experience required preferably with 5 years in Regulatory.
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Assists the Director of Regulatory Compliance with property level compliance with the Bank Secrecy Act (BSA) and FinCEN regulations and the Company’s BSA Title 31 anti-money laundering policy, to ensure the property is in compliance with regulations pertaining to money laundering.
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You will provide timely and proper investment reporting of General Account Invested Assets under applicable Statutory, GAAP, Management and Tax basis.
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Represent Regulatory Affairs in cross-functional team projects to support clinical trials and registration activities, as needed. Evaluate and develop standard operating procedures for the Regulatory Affairs department.
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The Manager, Regulatory Affairs North America, Acts as a top-level specialist on the global regulatory sub team and cross-functional project teams in the development of regulatory strategy and submission plans to ensure timely commercialization of new and modified products into North American markets.
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8+ years of AML, Regulatory Compliance and/or Model Validation experience in a financial services setting. RSM's AML/Regulatory Compliance group in association with our national Blockchain and Digital Assets team is currently seeking a strong resource to join our fast-growing Risk Consulting practice at the Manager level.
$92,100 - $185,400 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Coordinates and prepares document packages for regulatory submissions for new and mature products, ensuring compliance with local and regional registration requirements.
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The Safety Manager - Regulatory Compliance will lead a cross functional team that handles critical regulatory compliance programs throughout AmeriGas. The compliance responsibilities include Process Safety Management (PSM), Risk Management Program (RMP), Office of Pipeline Safety (OPS), and Department of Homeland Security (DHS) related activities.
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As a Regulatory Affairs Manager you will need to be experienced with In Vitro Diagnostic (IVD) Medical Device regulation and Laboratory Developed Tests within the United States under FDA. This role will be collaborating with IVD product development teams in the context of early phase drug development, providing regulatory strategy, regulatory writing and submission, authority interactions, and regulatory operational support.
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