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Requires Masters degree in Regulatory Affairs, Biomedical Engineering, or Medical Device Engineering, and six years of experience as a Regulatory Affairs Manager or Regulatory Affairs Specialist or related occupation in regulatory affairs, or a Bachelors degree in Regulatory Affairs, Biomedical Engineering, or Medical Device Engineering, and eight years of experience as a Regulatory Affairs Manager or Regulatory Affairs Specialist or related occupation in regulatory affairs.
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We believe that our PCVs could receive regulatory approval based on successful completion of clinical studies utilizing well-defined surrogate immune endpoints, consistent with how other PCVs have obtained regulatory approval in the past, rather than requiring clinical field efficacy studies.
$144,000 - $162,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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You will need to work closely with the Vice President, Global Regulatory Affairs Oncology and Precision Medicine, and collaborate with the biomarker team and global/regional regulatory liaisons to provide Precision Medicine global regulatory guidance.
$205,700 - $266,200Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Experience working with and building strong relationships with cross-functional departments in business, marketing, hardware and software engineering, product and project management, process and analytical development, regulatory and quality.
$90,000 - $210,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Director/Sr Regulatory Affairs will lead the overall CMC Regulatory strategy for Adverum’s gene therapy program/s. Manage the Regulatory Affairs (CMC) Strategy for Regulatory Affairs.
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Meta is seeking a highly motivated, organized, detail-oriented candidate to assist the Payments Compliance Team as an Investigator on the Transaction Monitoring Team. The Transaction Monitoring team manages reviews of platform transaction activity for potential red flag identification and regulatory reporting.
$90,000 - $137,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Using lessons we've learned at places like SpaceX and Blue Origin, Xona is constructing a modern satellite network at the rapid pace of the new space industry leveraging the recent wave of technology and regulatory advancements.
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The Director Global Safety and Pharmacovigilance (GSPV) Operations, Process, Quality and Compliance i s responsible for the establishment, maintenance and oversight of appropriate procedures, metrics, and systems to assure compliance to global regulatory requirements for the collection, processing, and reporting of safety information throughout the product life cycle, (pre- through post-marketing.
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Experience in leading the design and implementation of clinical pharmacology and biopharmaceutic studies including bioequivalence, bio-comparability, drug-drug interaction, special population, ethnic sensitivity, ADME and pediatric studies and integrating results into regulatory filings, and product labels.
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Ensure that each group has appropriate protocols to support tech transfer including process development, QA/QC, and regulatory. Experience interacting with government regulatory agencies is a plus (FDA, DEA, etc.
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Support regulatory activities, medical affairs, and payer engagements; represent Allogene in external scientific and medical forums. Understanding of the related disciplines (i.e. biostatistics, regulatory, pharmacology and toxicology research, cell therapy manufacturing, clinical pharmacology and pharmaceutical sciences.
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Establish appropriate strategic partnerships with internal leaders in clinical development, regulatory affairs, safety, operations, research, and commercial. Collaborate with legal, compliance, and regulatory authorities to ensure proper and ethical interactions between medical affairs personnel and external stakeholders.
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Familiar with regulatory standards and quality systems (e.g., GLP, GMP). Associate Director, Analytical Development, Raw Materials. Extensive hands-on experience in a wide range of analytical techniques, such as UV-Vis, HPLC, CE, SDS-PAGE, icIEF, LCMS, GCMS, enzyme kinetics, colorimetric and fluorescent plate-based assays, ELISA, Western Blot, etc.
$150Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Understanding of EMC/EMI testing for regulatory compliance and certification including SAR. Experience with regulatory requirements and process for wireless consumer devices, such as FCC, ETSI, PTCRB, etc.
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These activities include, but are not limited to, collaboration on functional area activities during program implementation, clinical pharmacology study start-up/execution/close out, PK-PD and related analysis, interpretation and reporting, and support of regulatory filings.
$205,700 - $266,200ExpandApply NowActive JobUpdated Today
regulatory job Title: sr regulatory affairs associate Company: Thermo Fisher Scientific in San Mateo, CA
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