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The FRM will need to coordinate cross functionally within Field Sales, Marketing, Market Access, Public Affairs, State & Government Affairs, Trade, and Specialty Pharmacy Account Management.
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Manager - Regulatory Affairs CMC page is loaded. Manager - Regulatory Affairs CMC. Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies.
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In this role, you will lead the legal support, including directly advising, educating BMS colleagues, staying current on evolving global regulatory, legal and policy environment for BMS’ work with digital solutions, including regulated patient and physician-facing digital health solutions (e.g., digital medicine and digital therapeutics) such as mobile applications, diagnostic algorithms, digital biomarkers, use of artificial intelligence and clinical decision support solutions.
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Licensed Speech Language Pathologist, State of New Jersey Department of Law and Public Safety, Division of Consumer Affairs, Audiology and Speech Pathology Advisory Committee pursuant to NJSA and NJCA. This includes a temporary license as approved by the NJ DOH personnel standards for early intervention personnel.
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The Internal Audit Control Manager - Compliance Subject Matter expert is primarily accountable for ensuring adequate and appropriate audit coverage of federal/state/GSE requirements applicable to the organization by maintaining the compliance matrix and providing input to the audit plan and advice to audit teams regarding consumer compliance regulatory applicability.
$97,000 a yearInternExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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As part of the GRA CMC Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs, Pharmaceuticals. Join Takeda as a Director, GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA CMC Pharmaceuticals regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM stages.
$165,200 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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ERM delivers a wide range of climate change services including decarbonization strategy development, creation of Scope 1, 2, and 3 carbon inventories, Task Force on Climate-related Financial Disclosure (TCFD) analysis and reporting, strategy development, policy and regulatory analysis, target setting, and benchmarking.
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Ensure close collaboration with other functional areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs, etc. Reviews and provides input to TLF shells for submission documents (e.g., Develops the process for ensuring that analysis data sets and outputs are compliant with regulatory requirements, including CDISC ADaM data set specifications, reviewer’s guides, etc.
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Knowledge of Bank Secrecy Act regulatory requirements, including CTRs and SARs, and basic knowledge of banking regulations. Our bank client is seeking to fill a BSA Analyst role in the Trenton, NJ area.
$70,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Join Takeda as a Director, GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA CMC Pharmaceuticals Oligonucleotide regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM stages.
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Perform assigned activities in accordance with Otsuka Standard Operating Procedures, and regulatory requirements. Maintains a thorough understanding and strict adherence to GCP guidelines and regulatory reporting regulations.
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Strong technical and business acumen, understanding of regulatory and industry frameworks (ISO, NIST etc.) Position Summary Reporting into the Global Manager Identity Access Operations, Lead AnalystPAM Operations will spearhead the implementation, management and enhancement of our Privileged Access Management system.
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Works collaboratively with regional directors, HRBPs, RHM management, and HR leadership to effectively identify, manage, and mitigate organizational risk, by ensuring HR compliance and consistency in the administration and delivery of colleague relations services; readily partners with key internal and external customers such as Risk Management, Legal Services, Integrity and Compliance, and other state and local regulatory bodies and organizations.
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In compliance with legal and regulatory requirements, the MSO will also lead when appropriate, in the design and implementation of risk mitigation strategies to ensure the safe and appropriate use of Janssen products.
$186,000 - $322,000 a yearExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Job Description/Qualifications: 10+ years of experience in land development design (preferably private sector) Must enjoy working on various project types including but not limited to: Industrial, Commercial, Retail, Residential, etc.
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regulatory affairs jobs Title: affairs project manager Company: Gpac in Trenton, NJ
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