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Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in Research and Development, Regulatory Affairs, and Clinical Development.
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Drafts and/or provides guidance to the drafting and execution of Verification and Validation test plans in compliance with LifeNet Health (LNH) Quality Systems (QS)/Regulatory Affairs (RA) standards in allograft design and development duties.
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Director, Model Validation for SHUSA Compliance models (Transaction Monitoring, Sanctions Screening, Fraud Risk, etc) will be responsible for leading the independent validation of models used by various Compliance groups in conformance with regulatory guidance on model risk SR- and other regulatory requirements around Compliance models.
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Minimum five years or more of recent experience in affordable housing with a portfolio in multiple states with an emphasis on HUD (Project Based Section 8), Rural Development, and LIHTC program compliance experience.
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The Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.
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Collaborate with cross-functional teams (process R&D, analytical development, supply chain, quality, clinical, regulatory, DMPK, and tox) to meet CMC and program goals. Extensive experience in late-phase drug product development and commercial development with CMC regulatory filings for the US (NDA), Europe (MAA), Japan, and China.
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Lead global CMC regulatory strategies for projects in development and marketed products, including risk mitigation strategies to ensure approvals and maintenance of product licenses. Demonstrated success in leading complex groups to support operational goals and contribute to the development of global regulatory initiatives.
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Incyte Corporation is seeking a motivated and experienced protein purification scientist to provide technical expertise in monoclonal antibody (including bispecifics) purification process development, characterization, and validation primarily for novel therapeutic monoclonal antibody products throughout all stages of clinical trials and commercialization.
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Design and implement development opportunities for the purpose of building an effective and engaged regulatory compliance team. Counsel on alcohol laws, regulations, and guidance documents with respect to complex regulatory issues relating to product development, product lifecycle management, manufacturing operations, quality, and M&A transactions.
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Focus on financial organizations that address SEC, CFTC, FINRA, NFA OCC and other regulatory requirements for retail and institutional broker dealer compliance, capital markets, banking, swap dealer trading, investment management, and investment advisor compliance.
$120,500 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Job Overview: Seeking a Process Chemist for our clients Process Research and Development team to oversee drug substance development and GMP manufacturing, requiring a proven track record in solving technical challenges.
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10+ years (Senior) or 15+ years (Principal) CMC experience in process or analytical development and/or QA/QC with regulatory experience in the pharmaceutical, biologics or combination product industry, with a history of successful investigational new drug and/or marketing dossier submissions.
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Ensures contract required documentation is complete for all projects and regulatory applications and RFIs/RFPs. Provides leadership, support and guidance to Alutiiq, LLC and its subsidiaries related to import/export compliance management, licenses, training, and auditing.
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Reporting to the Chief Operating Officer, the Vice President and Chief Compliance Officer is primarily responsible for overseeing health care compliance at Dana-Farber and development of a compliance program that ensures compliance with all major laws, regulatory requirements, policies, and procedures relevant to health care providers.
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Firm Type: Law Firm, Experience: 2 Years, Job Overview: A law firm in San Diego, CA, is seeking a skilled Transactional/SEC/FINRA/Regulatory Compliance Attorney with expertise in the Investment Advisers Act of 1940, Securities Act of 1933, Investment Company Act of 1940, and other relevant regulations in the financial services industry.
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regulatory compliance process development jobs Company: Albany Medical Center in Sanford, Florida
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