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The Team Lead for Authoring Support Group will be part of the Global Regulatory Operations group and will develop and manage the authoring support group within Regulatory Affairs (RA) to ensure timely and high-quality document delivery to the Regulatory Publishing Group.
$142,500 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Ability to interact successfully with internal and external stakeholders including Clinical Development, Regulatory Affairs , Drug Safety and Pharmacovigilance, Legal , Commercial, Sales and Marketing, etc.
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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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Reports to the Integrated TA Strategy Lead. Collaborates closely with cross-functional teams, including sales, marketing, medical affairs, market access and policy/advocacy (MAPA), regulatory affairs, and other relevant NNI departments to ensure alignment of brand objectives, strategies, and marketing promotion.
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Also, interacts routinely with colleagues across Market Access and Public Affairs, and internal stakeholders from Marketing, Medical Affairs, HEOR, Finance, Commercial, Field Sales, Government Pricing, and other relevant departments.
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Must be able to effective articulate and negotiate complex project related matters to FDA. Advanced understanding of pharmaceutical development and CMC regulatory affairs including regulatory guidelines, federal regulations and legal considerations.
$90,000 - $180,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Demonstrates knowledge of safety, including any emerging safety concerns and risk/benefit profile for responsible compounds, as well as regulatory guidelines as they pertain to drug safety/pharmacovigilance.
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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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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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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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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 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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Communicate frequently with other Respiratory Sales Specialists across the country and cross-functional counterparts such as Marketing, Sales Ops, Market Access, Field Reimbursement, Training, and Medical Affairs to create alignment of business plan, focus on strategic drivers, and sharing best practices.
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Full Knowledge of the drug development, study conduct processes, regulations related to Data Management and clinical research such as CFR Title 21, ICH Guidelines, EU Directives, GCP and relevant regulatory compliance.
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Broad understanding of pharmaceutical development, Regulatory Affairs, Quality Assurance, Safety and Commercial. The Project Manager, Regulatory Affairs Global Compliance and Planning is responsible for driving implementation of and adherence to best practices in project management.
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regulatory affairs jobs Title: sr regulatory associate Company: Thermo Fisher Scientific in Lawrence, NJ
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