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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. Manage the Regulatory Affairs (CMC) Strategy for Regulatory Affairs.
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The incumbent will report directly to Head of CMC Regulatory Affairs – Systems and Operations at Gilead. 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.
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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.
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You will collaborate closely with multiple teams across Process Development, Analytical Development, Regulatory Affairs, Quality and Manufacturing. You will collaborate closely with multiple teams across Process Development, Analytical Development, Regulatory Affairs, Quality and Manufacturing.
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The Administrative Division Director oversees and manages financial and administrative affairs of the Division of Critical Care Medicine, Pulmonary Medicine, and Quality of Life and Pediatric Palliative Care consistent with standards of performance that ensure University, School, LPCH, and Department business standards and objectives are met.
$200ExpandApply 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.
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The optimal candidate participate will lead the department and also collaboratively work across a team of peers in Clinical, Regulatory, Biometrics, Medical Affairs and Commercial and will be accountable for ensuring safety systems, staff and procedures are in place to support a compliant global pharmacovigilance system.
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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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Collaborate with regulatory affairs to ensure compliance with applicable medical device regulations and standards throughout the development lifecycle. Define project requirements, specifications, and timelines in collaboration with cross-functional teams, including engineers, researchers, medical professionals, and regulatory specialists.
$200ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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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Lead the Platforms (CTS and CX) Governance and Policy team and partner across Platforms and Robinhood's Business Entities (Brokerage, Cash, Crypto, Financial Crimes and others) to protect our customers and adhere to regulatory requirements by creating and maintaining a robust governance program.
$213,000 - $250,000ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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This position requires a comprehensive knowledge of SAS and CDISC standards, project and resource management, regulatory filing experience, and a broad understanding of the pharmaceutical drug development process.
$200ExpandApply 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
regulatory affairs jobs Title: sr Company: Csl Behring in Foster City, CA
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