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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 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.
$250Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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In-depth understanding of CMC regulatory requirements and experience with compiling CMC sections for regulatory filings. This position collaborates closely with cross-functional team members, including analytical development, quality assurance, manufacturing and process development, regulatory and clinical operations.
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In addition, the Sr Director will be accountable for leading the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally.
$150ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Experience advising clients on global policy matters, new legislative and regulatory developments, and legal and policy advocacy options and strategies. You will report to Verkada’s Deputy General Counsel and Chief Privacy Officer and play a significant role in shaping the direction of the privacy and AI programs.
$200ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Director of CMC Analytical Development's responsibilities will be:Create and put into place CMC analytical strategies to assist with drug development and regulatory submissions. Prepare and review CMC analytical sections of regulatory submissions, including IND, BLA, NDA, and MAA.Prepare for and develop data-driven responses to regulatory requests for information related to analytical activities.
$200,000 - $245,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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. Licensed mental health professional as confirmed by state regulatory/licensing board (e.g., LCSW, MFT, RN, or LPCC) from the state of operation.
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Broad understanding of all aspects of CMC including process development, regulatory and quality requirements, analytical development, formulation and drug product technologies, distribution across multiple regions.
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Partner with the hospital manager on regulatory compliance mandates. Our state-of-the-art facility includes Anesthesiology, Cardiology, Critical Care, Dentistry, Emergency, Integrative Medicine, Internal Medicine, Neurology, Oncology, Physical Rehabilitation, Radioactive Iodine Therapy, Surgery, and Urgent Care. About the role:As an Assistant Hospital Manager in our established Emergency and Specialty hospital, you will be responsible for the following:Spend the majority of work hours on the clinic floor, interacting with and supporting all departments.
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OPPORTUNITY Mammoth is hiring a Director/Sr. Director, Regulatory Affairs, Therapeutics, to lead the regulatory activities of our growing CRISPR-based therapeutic programs as we bring them from concept to market.
$205,000 - $260,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Familiar with regulatory standards and quality systems (e.g., GLP, GMP). 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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Partner with other teams involved in the end-to-end assay launch and maintenance processes, including Clinical Ops, Clinical Lab, Quality, Regulatory Affairs, Medical, Business Stakeholders, etc.
$150Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Prepare and provide input to clinical study reports (CSRs) and clinical portions of Regulatory Documents (, IB, DSUR, PSUR, regulatory responses)Participate or lead as needed the review and assessment of new opportunities and ESRs. Responsible for timely responses to investigational study sites for local ICF changes, protocol & EC/IRB questions/requests.
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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 Yesterday - UpvoteDownvoteShare Job
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Reporting to the SVP, Regulatory, Quality and Pharmacovigilance, you will work in partnership with a talented and collaborative team across our Research/Pre-Clinical, CMC, Regulatory, Clinical, and Quality organizations to author and drive development of key documents in support of all of our Phase 1 through Phase 3 programs.
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regulatory job Title: sr Company: Csl Behring in Burlingame, CA
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