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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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The Department of Pharmacology and Toxicology within Developmental Sciences is seeking an experienced regulatory/project toxicologist and strategic leader to develop and lead the execution of nonclinical safety strategy for gene therapy programs at Spark.
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Regulatory Coordinator Oncology Clinical Research Unit [CRU] Brain TUMOR CLINICAL Research Program [BTC] Position Description, Occupational Summary Perform regulatory and safety processes for multiple, complex oncology clinical trials and research studies including Investigational Products [IP] for the Duke Cancer Institute’s [DCI] TEAM Clinical Research Program [BTC.
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Experience and solid knowledge of Pharmacovigilance specificallyProficiency in one or more of these additional areas is a plus: CMC/Mfg., Clinical development and trial execution, Regulatory, Real-World Data and Real-World Evidence, Cell and Gene Therapy, Medical Device, IVD/CDxExperienced in understanding and interpreting regulatory guidelines and documents.
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The IRB Regulatory Consultant will oversee regulatory operations of studies conducted by one or more Disease and Modality Team within Montefiore Einstein Cancer Center, including, internal (investigator-initiated studies), Cooperative group, and industrial protocols (pharmaceutical and biotechnology company studies.
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Job Summary: The Sr. Regulatory & Compliance Specialist is responsible for assuring compliance with all food safety & regulatory matters, also for supporting the Sr. QA Manager in developing, implementing, and enforcing Food Safety Programs for the company (including SQF program), oversees the plant SQF program to ensure certification is maintained.
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4-8 years of litigation experience, preferably including experience at a top-tier law firm, government trial attorney, regulatory enforcement attorney or in-house counsel. Morgan Stanley is seeking a litigation attorney to handle a docket of arbitrations, civil litigations and regulatory enforcement investigations and inquiries for its Wealth Management business.
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Compliance with regulatory requirements, company policies (including GMP’s) and standard operating procedures (SOPs). Company representative for SQF, organic, kosher, halal, gluten free, non-GMO, and customer audits.
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Ensure compliance with regulatory requirements, company policies (including GMP’s) and standard operating procedures (SOPs). Trainings/ Certifications Required: •HARPC/ PCQI Certified•SQF Implementation & Auditing Certified •SQF Internal Auditing Training Essential Functions/ Duties and Responsibilities: 1.
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Serve as the subject matter expert on Veeva Vault and related clinical trial management systems (CTMS), electronic trial master file (eTMF), and regulatory document management systems. Expertise in Veeva Vault or similar clinical trial management systems (CTMS), electronic trial master file (eTMF), or regulatory document management systems.
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The Senior Accountant – Regulatory Reporting and Compliance is primarily responsible for preparing and filing required reports to the Federal Energy Regulatory Commission, Railroad Commission of Texas, and to other federal and state agencies.
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Deloitte Risk and Financial Advisory's Financial Services Industry (FSI) Risk, Data and Regulatory professionals help organizations identify the regulatory changes impacting their business and implement effective and efficient processes to manage regulatory, capital, liquidity and interest rate risks, respond to evolving regulatory environments and implement programs, measures, and tools to help clients with a specific focus on risk, data, and regulatory processes.
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Learn more about Deloitte's FSI Risk, Data and Regulatory practice. Deloitte Risk and Financial Advisory Risk, Data and Regulatory Liquidity - Manager. Exposure to firm-wide governance frameworks for liquidity risks, including enhancements related to the changing regulatory environment and compliance with regulatory expectations.
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Prior experience in compliance, product controllers, legal, regulatory, audit or risk management functions in the firm's various businesses, e.g., consumer banking, asset or wealth management and/or global banking and markets businesses.
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Good understanding of relevant areas such as biostatistics, regulatory, clinical pharmacology, pre-clinical toxicology, pharmacogenomics and biomarker-based approaches. Develop effective collaborations with research project leaders and projects team members, including biostatistics, regulatory affairs, clinical pharmacology, clinical scientists and development operations.
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regulatory job Company: Association For Community Affiliated Plans
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