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Our Client's FDA regulatory group works with broad range of companies, including medical devices, drugs, biologics, diagnostics, digital health, research tools, cosmetics, dietary supplements, wellness products, and other consumer products.
$365,000 - $435,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Past experience in quality control and analytical development, working with CMOs and testing labs, method development/validation, QC/stability support, conducting investigation, trouble shooting, and regulatory CMC support is preferred.
$133,280 - $172,480 a yearFull-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.
$191,335 - $247,610ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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 - $250,000Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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.
$237,660 - $307,560Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Ideal candidates will also have some contentious practice experience, such as working on regulatory investigations and/or litigation, ideally focused on tech, data, privacy, cybersecurity or related issues, have experience with drafting and reviewing data processing agreements, privacy policies, and security policies, as well as providing day-to-day privacy advice to in-house counsel and start-up executives.
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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.
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Experience in filing regulatory submissions from early development to pre and post approval submissions and product lifecycle management in the area of Cell Therapy. Maintain detailed knowledge of global regulatory environment relevant for cell therapies and regenerative medicine including accelerated review programs.
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This crucial role demands extensive expertise in the development and commercialization of small molecule pharmaceuticals, as well as a comprehensive understanding of regulatory requirements for rare disease therapeutics.
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Familiarity with data protection laws, including GDPR, CCPA, and HIPAA.Experience in incident response, risk management, and regulatory compliance in the cybersecurity domain. Regulatory Compliance: Monitor and interpret information security and cybersecurity regulations, and other relevant laws.
$214,500 - $321,700ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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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G., clinical operations, regulatory, preclinical, project management, quality, CMC, etc.) G., Medidata Rave, InForm, etc.) Experience in all aspects of protocol conduct, both early and late phases, including protocol writing, start-up, study execution, analysis, and reporting Sufficient content expertise to be able to meaningfully contribute to document development and data review and interpretation under the direction and oversight of the CMO. Knowledge of applicable FDA Code of Federal Regulations, Good Clinical Practices, and clinical trials guidelines is required.
$250,000 - $315,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Performs source data verification of clinical data entered into Electronic Data Capture (EDC) system or paper CRFs to ensure regulatory and protocol compliance and overall accuracy of the study data.
$115,000 - $125,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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You will be the principal face and our voice in the Europe and MENA markets, building impactful relationships with prospective customers, channel partners, and important hydrogen policy and regulatory influencers.
$150Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Serve as the inter-department subject matter expert for EDC platforms (Veeva, Medidata, Omnicomm) including management of the environment as well as the standards library to enable planning, coordination, and timely delivery of complete, high quality and reliable clinical trial data for internal decision-making, regulatory approval, and market acceptance.
$114,000 - $145,000 a yearFull-timeExpandUpdated Yesterday
regulatory job Title: pharmacy tech Company: Abrazo Health in Foster City, CA
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