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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.
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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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The Director/Sr Regulatory Affairs will lead the overall CMC Regulatory strategy for Adverum’s gene therapy program/s. The Director/Sr will be responsible for developing, executing, and advising on global Regulatory CMC strategies through all phases of Adverum’s development program/s.
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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.
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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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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.
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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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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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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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Lead the authoring and review of safety sections of regulatory submissions, e.g., IND/CTA (General Investigational Plans, China Risk Control Plans), NDA/MAA (SCS/ISS, RMPs, initial Package Inserts) collaborating with PSLs and other Clinical Study Team (CST) members.
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Statistical Programming- Analysis Programming: Statistical programmers work collaboratively with internal colleagues and external vendors to ensure the efficient, high-quality production of analysis datasets and statistical outputs for study reports and integrated summaries in support of Gilead's regulatory, scientific and business objectives.
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regulatory job Title: sr regulatory associate Company: Thermo Fisher Scientific in Foster City, CA
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