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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 CMC Regulatory Affairs Sr. Manager at Gilead is responsible for providing strategic direction, operational support, and technical expertise for. Initiates process improvements and contributes to global process improvements, which have a significant impact for the Regulatory Affairs CMC Department or development matrix teams.
$199,320 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Experience with academic administration or faculty affairs is helpful, but strong communication, both oral and written, and teamwork skills are critical. Act as a local resource for the school or department on academic and faculty affairs policies and processes related to faculty searches and recruitment.
$41.35 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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This role will oversee the development and implementation of statistical programming strategies, manage a team of statistical programmers, and collaborate closely with cross-functional teams to ensure high-quality deliverables that meet regulatory requirements and support drug development efforts.
$190,000 a yearFull-timeExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
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This position is an individual contributor role with expectations to be hands-on and will report to the Sr. Director of Regulatory Affairs and will liaise closely with regulatory and cross-functional teams at Guardant Health to bring innovative diagnostic assays to market and keep them compliant.
$177,000 a yearFull-timeRemoteExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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You will work across multiple frameworks and regulatory standards including, but not limited to, NIST CSF, ISO, GDPR, SOX, PCI, FedRamp, SOC2 etc. Rubrik is investing in these areas to address the evolving cybersecurity threat landscape, as well as regulatory compliance requirements as the company continues to grow.
$259,600Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Author/review and/or coach team members to author CMC regulatory sections of IND/INDa. Contribute to regulatory strategies and support associated agency interactions and product-related inspections.
$247,610ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Drug Metabolism and Pharmacokinetics (DMPK) group is seeking a candidate for the position of Research Associate with the primary responsibility to providing bioanalytical support to biologics discovery project teams.
$51 an hourExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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The Director, Regulatory Affairs will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC disciplines in support of investigational studies.
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Prepare comprehensive model validation reports detailing findings, recommendations, and conclusions for senior management, regulatory bodies, and auditors. Stay up-to-date with the latest developments in risk modeling techniques, industry standards, and regulatory guidelines, proactively identifying opportunities to optimize and enhance our model validation processes.
$285,000Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The (Sr.) VP/Head of Regulatory Affairs will lead the company’s regulatory strategy and operations. Establish and maintain regulatory affairs systems, ensuring accurate record-keeping and data management.
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Interact effectively with Regulatory Counsel and Compliance to ensure appropriate handling of regulatory/compliance issues in contract matters. Juris Doctor (JD) degree plus 4-6 years of experience with pharmaceutical or healthcare legal matters in-house and/or law firm is required.
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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. Under direct supervision of the Clinical Director/Administrator, this Licensed Team Lead entry-level management position supervises multidisciplinary teams, coordinates service needs, and collaborates with other services and agencies.
$136,029.34 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Provide strategic legal counsel on issues related to deal structure, regulatory compliance, and post-transaction integration. A law firm in Palo Alto, CA, is seeking a highly skilled M&A/Private Equity Associate Attorney with 4-7 years of experience.
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This investigation includes but is not limited to a criminal, civil litigations and regulatory review, employment, education, and credit review (role dependent). We assist companies and non-profit organizations in delivering benefits to their employees.
$75,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday
regulatory affairs jobs Title: sr director Company: Planet Pharma in Redwood City, CA
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