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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 are seeking a driven, creative, collaborative, and highly respected individual who is passionate about public policy, government affairs, regulatory policy, helping patients, innovative science, biotechnology, and public health to serve as Vice President, Policy & Advocacy.
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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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The Department of Genetics is seeking an experimental or hybrid experimental/computational research associate in genomics (Life Science Research Professional 1) to join the Engreitz Laboratory to map the regulatory wiring of the human genome to discover genetic mechanisms of heart diseases.
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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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A law firm in Palo Alto, CA is seeking a Junior Digital Health Associate Attorney with 2-4 years of experience in healthcare law and regulatory compliance. Provide comprehensive legal counsel to digital health clients on regulatory compliance issues, including HIPAA, Anti-Kickback Statute, Stark Law, and False Claims Act.
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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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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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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.
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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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Licensed mental health professional as confirmed by state regulatory/licensing board (e.g., LCSW, MFT, RN, or LPCC) from the state of operation. Free CEUs, free Supervision for BBS Associate License, coaching and mentorship.
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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 - UpvoteDownvoteShare Job
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In this position, you will work closely with the Process Development, Quality Control, Quality Assurance, Translational Medicine, Biometrics, and Regulatory team members and will contribute to novel assay development for product understanding of CARGO Therapeutics' pipeline candidates, fit-for-purpose method qualification, SOP/technical report authoring/review, life cycle management of assays, data analysis, and execution of routine analytical testing.
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regulatory job Title: sr regulatory affairs associate Company: Thermo Fisher Scientific in Redwood City, CA
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