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Support FDA regulatory requirements by following an established Product Development Process. The position requires knowledge of FDA regulatory processes for IVD products. Educate and coach team members on FDA compliance issues.
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Ongoing tracking and evaluation of legal and regulatory developments at the Federal and state levels pertinent to the commercialization of innovative pharmaceuticals, including but not limited to guidance and advisories from FDA, OIG, DOJ, CMS, and other relevant government agencies.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Strong knowledge of regulatory guidelines (e.g., ICH-GCP, FDA, EMA) pertaining to TMF. Implement and maintain TMF quality control processes that are aligned to internal standards, regulatory requirements, and GCP.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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The Regulatory Compliance Specialist provides critical support in product management to bring new and renewal import products (mainly from South Korea) to market quickly and under compliance. Ensure FDA/USDA/CFIA labeling compliance of import product including translation and labeling information verification.
Full-timeExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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Liaison with the food industry’s Process Authority on food safety issues; liaison with FDA regulatory personnel and foreign suppliers on thermal process issues. Partner with Senior Manager of Regulatory Affairs and Nutrition who manages the Consumer Affairs staff, to review new or revised letters, and track and recommend action on consumer claims as necessary.
ExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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Assist in preparation for AAALACi site visits, Institutional Animal Care and Use Committee (IACUC) inspections, Medical Research and Materiel Command (MRMC) Animal Care and Use Regulatory Office (ACURO) staff assistance visits, and inspections by Food and Drug Administration (FDA), Centers for Disease Control (CDC), the Department of the Army Inspector General (DAIG) or similar entities.
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Oversees all the day-to-day operations involved with the collection, processing , cryopreservation, storage and release of high quality cellular therapy products including umbilical cord blood, adipose tissue, adipose tissue stem cells, dental pulp stem cells and other cell therapy products and must ensure that these activities are compliant with the FDA, AABB, NMDP, HIPAA and other regulatory bodies.
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Prepare and manage regulatory applications to federal and local agencies (FDA, NIH, IRB, etc.) Our projects include but are not limited to clinical trials in addiction, infectious disease, neurology, cardiovascular critical care, novel point-of-care test devices, behavioral health emergencies, advanced care planning, and state-of-the-art digital health innovations such as digital pills, emergency ultrasound, and other novel medical technology.
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Accountable for organ recovery staff adherence to all regulatory and accrediting agency standards, including, but not limited to CMS, UNOS, AOPO, FDA and AATB, as well as all internal Infinite Legacy organizational policies, procedures, and guidelines.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Knowledge of other regulatory, compliance, and legal issues related to health care including (1) FDA Regulations (and other international equivalents); (2) ICH-GxP requirements; (3) global medical device and in vitro diagnostic registration requirements; (4) transparency laws; and (5) human biological specimen regulations.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Ensure that the clinical trial sites are compliant with applicable regulatory requirements (e.g., FDA, ICH, GCP, ISO) regarding ophthalmic drugs / devices. Conduct on-site and remote monitoring visits according to the protocol monitoring plan to ensure data quality and regulatory compliance.
$71.43 - $85.71 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Experience in a pharmaceutical, Federal Drug Administration (FDA), other controlled regulatory agency or Current Good Manufacturing Practices (cGMP) packaging or manufacturing environment is preferred.
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Minimum of 8 years of relevant pharmaceutical industry experience, including at least 5 years in a strategic position in regulatory affairs with proven experience (filing and defense of major submissions such as IND/NDA/BLA/CTA/MAA.
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Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.) Lead cross-functional projects for the installation and qualification of new analytical instrumentation, ensuring projects are completed on time, within budget, and in compliance with regulatory standards.
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Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable.
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