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Influence and shape the regulatory landscape and future regulations with support from a more senior regulatory affairs team member. The Senior Manager, Regulatory Affairs will manage the development and execution of biosimilar regulatory strategy; drive submission related activities and achieve timely filings of regulatory submissions consistent with regulatory requirements to achieve short approval times of critical Biosimilars products.
Full-timeExpandUpdated 19 days ago - UpvoteDownvoteShare Job
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CCRP - Cert Clin Research Prof (Preferred) or RAC - Regulatory Affairs Cert (Preferred) 2 Years experience in a regulatory role or 4 Years experience in related clinical research role (Required.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Reporting to: Senior Director, CMC Regulatory Affairs, The Manager/Sr. Manager, Technical Writing - CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs plays a critical role in ensuring compliance with regulatory requirements pertaining to drug development and manufacturing processes.
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The Project Manager will also be responsible for engaging with the Institutional Review Board (IRB), regulatory affairs, and the Office of Clinical Research to generate documents for AE reporting, continuing review, protocol modifications and study start-up and closeout.
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Engaging with the Institutional Review Board (IRB), regulatory affairs, and the Office of Clinical Research. irb, regulatory, submission, adverse events. engaging with the Institutional Review Board (IRB), regulatory affairs, and the Office of Clinical Research.
$40 - $45.67 an hourExpandUpdated 10 days ago - UpvoteDownvoteShare Job
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Transamerica is organized by lines of business (Life Insurance, Annuities, Mutual Funds, Retirement Plans, and Employee Benefits), which are supported by Transamerica Corporate (Corporate Development; Finance; Internal Audit; Legislative, Regulatory & Policy; Office of the CEO; People and Places; Brand; Corporate Affairs; Risk; and Technology.
Work from homeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Assist with general activities of the quality department as required, including the maintenance of various files and information systems including customer and copacker specifications, general correspondence and product manuals, label/product QC hold database, and regulatory affairs activities.
ExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Interest in healthcare administration, compliance, and regulatory affairs is preferred. Stay updated on industry trends, regulatory changes, and best practices related to compliance and credentialing in the healthcare sector.
RemoteExpandApply NowActive JobUpdated 10 days ago
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