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Understanding of US promotional codes/regulations, FDA regulatory submission process, and/or US labelling. As Scientific Director, Specialty Pipeline you will use your clinical and scientific training to define and drive the medical affairs business planning strategy for assets at various stages of development.
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Environmental Monitoring, Pharmaceutical Manufacturing, Science, Microbiology, Biology, Sampling, FDA, GMP, Biology, Durham, North Carolina, NC, Comprehensive Benefits Package, Health, Vision, Dental #Pando.
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Conduct training to ensure regulatory compliance and continuous improvement in food safety and quality practices (SQF, GMP, HACCP, etc. FISMA/FSIS/FDA/SQF working experience and knowledge of governmental regulations.
$70,000 - $90,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Understanding of CFR Parts 210, and 211, ICH, and FDA regulatory guidance related to pharmaceutical development, manufacturing and specifications. As a key member of the team, you'll collaborate cross-functionally to ensure the seamless transition of processes from R&D formulation development phase to commercialization, while adhering to strict regulatory guidelines.
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Act as site SME during regulatory inspections for managed programs (including FDA and other audits) Can manage decisions within the SOP, std practice, and regulatory framework for compliance areas and can manage peer, subordinate and cross functional conflict resolution.
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Supports regulatory compliance to ISO, FDA, and other worldwide regulatory requirements as appropriate through customer complaints, internal audits and training systems. The Regulatory Affairs Manager is responsible for coordinating the regulatory activities for projects including new products and life cycle management.
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Familiarity with pharmaceutical regulatory standards, including USP/ICH/FDA/cGMP/safety. Ensuring the accuracy of analytical measurements and compliance with cGMP, US FDA, and other regulatory and corporate requirements.
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Any employee entering a KBI site located in the US must either (1) have provided proof of full vaccination (as defined by the CDC) with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization; or (2) perform weekly COVID-19 testing with negative test results.
$24 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Continuously evaluate and evolve Validation Policy and Procedural level documents to ensure compliance with current regulatory (FDA, etc.) Serve as internal expert on validation in support of partner and regulatory audits.
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Maintains functional knowledge of relevant safety codes and standards of regulatory bodies including, but not limited to, The Joint Commission (TJC), National Fire Protection Association (NFPA), Food and Drug Administration (FDA), Nuclear Regulatory Commission (NRC), Association for the Advancement of Medical Instrumentation (AAMI.
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Compliantly adhering to FDA and other regulatory guidelines, the Patient Navigator takes ownership of the patient journey, expertly guiding individuals through the complexities of obtaining prescribed medication.
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This Environmental Monitoring Technician will play an integral role in ensuring every single material inside our client's product is manufactured, processed, tested, packaged, stored and distributed aligned with their incredibly high standards of quality and meets all regulatory requirements.
$65,000 - $75,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance.
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We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology.
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This documentation is completed in accordance with regulatory body requirements, the Office of Healthcare Technology Management (HTM) Documentation of Services policies and guidelines, and other VA requirements.
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fda regulatory jobs in Durham, NC
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