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We 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.
$85,000 - $144,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Strong knowledge of pharmacokinetics and pharmacodynamics principles, immunogenicity, modelling and simulation, Model-Informed Drug Development, ADME Concepts, and regulatory clinical pharmacology requirements to support clinical development and regulatory submission.
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Director, Model Validation for SHUSA 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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Maintain required documentation according to DDS, DMH, MassHealth, HUD, DPH, CARF and all applicable regulatory standards as well as Bridgewell policies and procedures. Provide services to individuals according to DDS, DMH, MassHealth, HUD, DPH, CARF and all applicable regulatory standards, as well as Bridgewell policies and procedures.
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5+ years working in the pharmaceutical industry, and strong experience writing CMC regulatory sections (including IND’s/ CTA’s) Author and manage process for CMC regulatory documents including module 3 CMC submissions, technical reports and SOPs.
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Experience in bioanalytical assay development and qualification based on regulatory guidelines. Preparing RNA and proteins from cell or animal samples and analyzing these samples by qPCR, ELISA, MSD, next-generation sequencing, or Western blot analysis.
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Complete audits to assess accuracy and quality of scientific data submitted to the regulatory agencies in support of in vivo medical devices and in vitro diagnostic devices' application. QualificationsTo be considered for this role, you’ll require a minimum of 5 years of professional experience in relevant field of healthcare products or related activities e.g.:Work in medical devices industry and/or in vitro diagnostic devices(preferred) or closely related industries (e.g., pharmaceutical industry) such as research and development, manufacturing, quality management, regulatory affairs.
$103,500 - $170,800 a yearFull-timeRemoteExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Responsibilities of the Medical Laboratory Technologist-Histocompatibility:Monitor lab performance/regulatory compliance/final review of daily, weekly, monthly, and annual surveillance documents.
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As part of the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs – Pharmaceuticals. Join Takeda as a Senior Director, GRA Pharmaceuticals- Small Molecule where you will establish collaboration with Global CMC teams and leadership through networks and enable CMC regulatory team’s success in meeting goals/objectives.
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Act as a liaison between cross-functional teams, including clinical operations, regulatory affairs, finance, and business development, fostering strong communication and collaboration throughout the contract lifecycle.
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The Security Agent primary responsibilities are but are not limited to the following; Retail cannabis sales are highly regulated and must operate in a safe and secure environment in full compliance with all regulatory requirements.
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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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Collaborate with Legal and Compliance teams to interpret regulatory guidance and assess the impact of regulatory changes on IT asset management practices, ensuring timely implementation of necessary controls and processes.
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Expertise in commercial healthcare and FDA regulatory law, specifically related to market access, pricing and price reporting, patient support, government contracting matters, and other laws and regulations related to the development and commercialization of pharmaceutical products.
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Knowledge of regulatory requirements and compliance standards related to procurement activities within the offshore wind sector. Or add your expertise to our supply and trading operations, brokering renewable electricity, green gas, commodities, and CO2 emission allowances from one of our advanced energy trading floors.
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regulatory job Title: director Company: Govhr Usa in Boston, MA
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