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In the position of Regulatory Program Director in Roche / Genentech Pharma Technical Regulatory (PTR), you will be accountable for Health Authority interactions pertaining to CMC Information (i.e.: CMC information in an IND, IMPD and NDA/BLA/MAA filings), as well as informational and pre-submission meetings with global Health Authorities, partners and industry experts.
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Capability in managing deliverables essential for regulatory permit applications, CEQA documents, and environmental due diligence investigations (e.g., wetland delineations, rare plant surveys, habitat assessments, biological resources technical reports.
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As the newest Regulatory Affairs Manager, you will be responsible for registering current and newly acquired crop protection products in the U.S. and other regions (Asia/Pacific, Latin America, Africa, Europe, and Canada.
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Competency in managing the work products needed to support regulatory permit applications, CEQA documents, and environmental due diligence investigations (e.g., wetland delineations, rare plant surveys, habitat assessments, biological resources technical reports.
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Ability to create procedures to interpret and align with regulatory policies, while enabling investigators perform appropriate level of due diligence. To be successful in this role, you must have a demonstrated ability leading a global trade compliance function, with a special focus on economic sanctions and foreign trade laws.
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In this role you will join a team of program managers, uphold and maintain the Cash App product’s licensing and regulatory obligations, and manage projects and strategic initiatives concerning parties external to Cash App, such as regulators, partners, and consultants.
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At Mercury regulatory compliance is not just a necessity but a competitive advantage that can set us apart as the leader in the space. Your team will manage all of our existing and future regulatory relationships, helping to establish Mercury's reputation as an effective steward of the financial system.
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Job Overview: A law firm in San Francisco, CA, is seeking a Mid-Level Environmental Associate Attorney with significant expertise in environmental law, encompassing regulatory counseling and litigation.
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This will require a deep knowledge and understanding of end-to-end business process, security frameworks (e.g. NIST, ISO, HIPAA and HITRUST), regulatory compliance (e.g. PCI, GDPR, SOX, etc.) Experience in security frameworks (such as NIST, ISO; knowledge of HIPAA or HITRUST also a plus) and regulatory compliance reporting (such as PCI and/or SOX.
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Strong knowledge of pharmacokinetics and modeling, pharmacodynamic principles, ADME concepts, bioanalytical principles, regulatory guidelines and clinical pharmacology requirements in late stage clinical development.
$220,000 - $240,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Experience working with and building strong relationships with cross-functional departments in business, marketing, hardware and software engineering, product and project management, process and analytical development, regulatory and quality.
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Design and implement a framework, process and policies for IT risk management including information security, regulatory compliance, and operational continuity risks. This role will own the overall framework and process for IT risk management, including information security, regulatory compliance, and operational continuity risks.
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Experience in analytical development or CMC, demonstrating proficiency in methodologies, data analysis, and regulatory compliance within the pharmaceutical or biotechnology industry is preferred.
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Our Legal team is responsible for all of Tools For Humanity’s global legal and regulatory affairs. Identify and know when to seek support on key regulatory issues (e.g., securities, payments, money transmission, data protection, sanctions/export controls, AML/KYC, tax.
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Provide leadership to early-stage clinical scientists on the clinical study team for Early Clinical Development, working in a matrix team environment with other clinicians, statisticians, clinical pharmacologists, translational biologists, drug safety/pharmacovigilance, clinical supply, and regulatory specialists.
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regulatory job Title: regulatory affairs assistant Company: Astrazeneca in San Francisco, CA
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