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Prepare and review CMC/Quality sections of US and ex-US regulatory filings. Responsibilities: Leads with strong leadership command, for all aspects of quality control and effectively manage employees Participates in all regulatory audits and inspections.
$240,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Manage CMC regulatory changes throughout the product life cycle, including support for relevant quality systems related to change control, discrepancy management, as well as Health Authority inspection support as required.
$329,000 a yearFull-timeExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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The Senior Manager, CMC Regulatory Affairs is a hands-on and independent role requiring a strong individual who will provide strategic and operational support to multiple programs, with an emphasis on CMC (Chemistry, Manufacturing, and Controls.
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Stays updated on evolving CMC regulatory guidelines and provides guidance and interpretation of CMC regulatory requirements, regulatory intelligence and benchmark information to Acumen teams and senior management, ensuring integration of CMC regulatory considerations into product development plans.
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New product setup and management of related projectsAssist with Supplier audits, as neededMaintenance of BSE Serum Certificates of Suitability filing with EDQMCollaborates with USDA on regulatory compliance activities including regulatory approvals, import/export compliance, traceability, quarantine, safety testing and affidavits.
$51 - $55ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Collaborate with cross-functional teams (process R&D, analytical development, supply chain, quality, clinical, regulatory, DMPK, and tox) to meet CMC and program goals. Extensive experience in late-phase drug product development and commercial development with CMC regulatory filings for the US (NDA), Europe (MAA), Japan, and China.
$118 an hourFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Our client is looking to fill the role of CMC Regulatory Affairs Manager. Provide CMC regulatory strategy for investigational, new and marketing products (biologics and small molecule focus.
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What we look for: A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD. Demonstrated organizational leadership skills at both functional and enterprise levels.
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This position involves working closely with cross-functional colleagues including regulatory operations, quality, CMC, nonclinical and clinical team members. Provide hands-on support in the generation of CMC documents (e.g., Module 2 and Module 3 of eCTD, IMPD, QOS, etc.
$235,000 a yearFull-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); and/or post-approval submissions.
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Hands on experience with at least one of the functions in CMC development such as Process Chemistry, Process Engineering, Formulation, and Analytical Chemistry. Minimum 5 years of experience working in a pharmaceutical biopharma dev / CMC organization with hands on experience leading digital transformation initiatives.
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Provides CMC regulatory guidance to manufacturing and quality teams; evaluates CMC change controls. Provides interpretation of regulatory guidance documents, regulations and directives – advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs.
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Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.
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The QC Analyst is responsible for supporting Quality Control bioanalytical testing for release of clinical and commercial products. Hands-on experience with various bioanalytical techniques including ELISA, qPCR and FACS.
$37 an hourExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD.
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quality control tech hands on cmc regulatory jobs
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