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Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred) Genmab is looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.
$170,625 a yearExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs. This role may also lead the Core Medical Team, Project Team (co-chair), and National Advisory Board meetings for a Therapeutic Area in certain instances, at the discretion of Executive Director of Medical Affairs.
Full-timeRemoteExpandApply NowActive JobUpdated 18 days ago - 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 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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Serves as a delegate for Executive Director for collaboration with Document Management team and Regulatory Affairs to ensure proper maintenance, retention and archiving of all Patient Safety records.
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Uses an understanding of disease biology, the drug development process (particularly cross-functional connectivity), and relevant late-stage challenges (e.g., trends in disease area therapeutic advances, and evolving regulatory, patient advocacy and market access environments) to create a vision for each asset, then design and execute effective development programs in support of the overall R&D portfolio goals.
Full-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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Support project teams, regulatory affairs, product management, marketing, and product stewardship in topics related to toxicology and kinetics. The position is located in Princeton, NJ and is part of the global Regulatory Affairs Toxicology Group.
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Lead the launch planning process for APOC’s game-changing TBI test; define regulatory, market access, pricing, distribution, sales force organization and promotion strategies and develop sales forecasts.
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Perform and coordinate project work involving site investigation, utility location and clearance, risk assessment and remediation of soil, groundwater, and sediments with moderate to complex technical/regulatory issues with manufacturing, power, chemical, oil & gas, and technology sector clients.
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Work closely with individual clinical teams as well as functional area partners (e.g., Translational research, Precision Medicine and diagnostics, Regulatory Affairs, Market Access, Clinical Development) to identify and implement end-to-end Data Science solutions aimed at facilitating decision making.
$142,000 - $244,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - 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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Utilizes software systems, including Medicat, PeopleSoft, a BASICS Feedback Survey tool, and Microsoft Outlook and Excel, to manage referrals to and from BASICS as well as scheduling and the online assessment students complete as part of BASICSCollaborates closely with colleagues across University Health Services and from across campus, including the Office of the Dean of Undergraduate Students and Graduate Student Affairs, to receive referrals and educate campus partners about BASICS.
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Knowledge of Bank Secrecy Act regulatory requirements, including CTRs and SARs, and basic knowledge of banking regulations. BSA Analyst responsibilities include: Administering the Bank Secrecy Act/Anti-Money Laundering Program and related procedures in accordance with Bank’s policies, procedures, and applicable federal regulations.
$70,000 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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S/he will work cross-functionally with other leaders and functions (including all Medical Affairs functions, Commercial, Compliance, IT, Finance, Clinical Development and Legal) to drive from inception to completion all Rare Disease MA workstreams and projects and to provide relevant medical input on the strategic and tactical support for DAYBUE (trofinetide) in the US and in OUS markets.
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Ensure the local HSE management system is effectively designed, implemented, and controlled and meets Firmenich standards, ISO standards, and all relevant regulatory requirements. Thorough knowledge of OSHA regulations and experience working with regulatory agencies.
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Work in close collaboration with colleagues in R&D Quality Management, operational units in Drug Development (Clinical Development, Clinical Operations, Data Management, Manufacturing, Medical Affairs, Laboratories, Pharmacovigilance, Regulatory Affairs, Translational Medicine, vendors (CSPs) and partners in GMP QA.
ExpandApply NowActive JobUpdated 3 days ago
regulatory affairs jobs Title: affairs project manager Company: Gpac in Lawrence, NJ
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