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Responsibilities of this position are that of a Regulatory Compliance Coordinator for the Animal Care Project. The Regulatory Compliance Coordinator (RCC) shall have detailed knowledge of federal regulations and policies related to use of animals in research.
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We are seeking a global Executive Director, Regulatory Affairs, Gene Therapy (level determined by candidate experience) reporting into the SVP Clinical Operations who will serve as the strategic lead representing regulatory affairs expertise managing the strategy and operational aspects of all regulatory submissions (INDs, NDAs, MAAs, etc.
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Leads regulatory compliance-related project and program management meetings with participation from internal and external stakeholders. The Senior Regulatory Operations Analyst is an advanced-level professional position responsible for a wide range of tasks in support of various regulatory compliance functions in Market Regulation and Transparency Services (MRTS), including those related to managing conflicts of interest-related compliance issues and inquiries and maintaining department-wide administrative policies and procedures.
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The Regulatory Affairs Manager (RAM) is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables.
Full-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Will serve as a key strategic partner representing Global CMC Regulatory on Regulatory Networks and Matrix Teams, providing and overseeing strategic direction and guidance to Biopharmaceutical, Pharma Supply Chain, Clinical Trial Supply, Quality Assurance, and Commercial interfaces on both global project and key strategic business initiatives.
Full-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Minimum of 10 years business experience with at least eight (8) years of experience in enterprise risk management or operational risk management, and relevant experience in the regulatory/financial services industry.
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Substantial knowledge of, and experience with regulatory requirements, regulatory guides, ASME Code requirements, AISC Code requirements, ACI Code requirements (318, 349 and 359), and other related industry codes and standards and/or industry/NRC initiatives in the area of structural engineering.
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This position reports to the Director, Contracts and Price Reporting and works closely with the Director of Contracts, Director of Strategy, Finance, Legal and Regulatory Affairs. Job Summary: The Manager/Senior Manager, Government Reporting & Pricing Analysis is responsible for ensuring compliance with statutory reporting requirements including Centers for Medicare and Medicaid Services (CMS) the Department of Veterans Affairs (VA), Public Health Services (PHS), and any state price reporting requirements.
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Interface with other support groups at DSM-Firmenich, e.g. Regulatory, Sensory, and Industrialization to ensure project success. Per Customer Request or project brief - lead project team and manage creative briefs to meet project objectives with little/no management supervision.
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Familiarity with FDA regulatory process. Specifically, this project will support OND’s Integrated Review for Drug Marketing Applications program by providing comprehensive safety data analyses for new drug applications (NDAs) and biologics license applications (BLAs) in collaboration with clinical reviewers.
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As a CMC RA Associate Director Project Leadership, you will provide regulatory CMC knowledge and progressively increasing levels of expertise to TA and non-TA projects within Global Regulatory Affairs(GRA) and AZ technical functions.
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Familiarity with areas of scientific knowledge relevant to pharmacopeial work including biologic drugs, excipients, active pharmaceutical ingredients, dietary supplements, analytical and pharmaceutical manufacturing instrumentation, quality control, regulatory science, basic statistics, metrology.
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Lead and shape future clinical development strategy and clinical development plans, working closely with Development and Discovery Program Leads and counterparts in Regulatory, Clinical Development, Clinical Operations, Biostatistics, Clinical Pharmacology, Medical Affairs, Commercial, Non-clinical and Discovery Research for assigned studies.
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Keeps abreast of and ensures compliance with regulatory practices (e.g. FDA, EMA, and ICH guidance and recommendations) and industry data standards (e.g. CDISC). Represents Emmes at Sponsor, Regulatory, Investigator or Safety Review meetings (e.g., Data and Safety Monitoring Board Meetings.
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Piper Companies (Health & Sciences) is seeking motivated candidates for a Specialist, Regulatory Affairs opportunity in the Rockville, MD Area for immediate assistance with an established research firm supporting critical research trials.
$40ExpandApply NowActive JobUpdated Yesterday
regulatory job Title: regulatory affairs project manager Company: Jobget in Rockville, MD
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