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In this role, you will provide hands-on, day-to-day technical and strategic leadership and work closely with cross functional teams in Analytical Development, Process Development, Global Quality and Regulatory Affairs-CMC, and our partners in in the commercial/manufacturing to support commercialization of our company's large molecule products.
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Ability to address key CMC regulatory questions that enable clinical studies and support marketing authorization applications. Our team is looking for experienced, creative, and energetic candidates to lead unit operation development and process optimization of synthetic drug candidates to support clinical trials, regulatory submission, and product commercialization.
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Develops/Reviews Stormwater Management Reports and Stormwater Pollution Prevention Plans (SWPPP) to support regulatory permits; + Conversant with regulatory codes, design codes and standards, best management practices, permit requirements and construction practices.
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Knowledge of Data Historian (OSIPI) Knowledge of Computer System Validation lifecycle and FDA regulatory requirements. PACIV, an international control systems integration, and regulatory compliance engineering firm, servicing Bio-Pharmaceutical, Medical Device, F&B, and Utility clients, is looking for a regular employee-based Senior Automation Engineer team member to join our team based in the USA office (Indianapolis) Job Description : The Sr. Automation Engineer will be twofold.
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Responsibilities:- Ensure compliance with regulatory requirements for working with animals in biomedical research, including the Animal Welfare Act & Regulations, the Guide for the Care and Use of Laboratory Animals, local policies, and other applicable regulations.
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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). Certified Financial Planner (CFP) - Issuing Authority, Series 07 - FINRA, Series 63 - FINRA, Series 65 - FINRA, Series 66 - FINRA.
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Stays up to date with knowledge of regulatory affairs and/or issues. Ensures compliance with regulations, including organizing electronic files and/or filing regulatory documents appropriately; prepares and submits Institutional Review Board (IRB) documents (i.e., Informed Consent, advertisement, protocol and protocol summary); prepares regulatory documents for sponsor.
$39,686.4 - $52,603.2 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Articulates the regulatory framework governing the role of the Spiritual Counselor (federal and state, if applicable). Ability to counsel patient and family and assist local clergy in rendering pastoral care.
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Function as the primary QA representative in CMO change management, investigation and CAPA review and approval, while adhering to regulatory, technical and business requirements. The Senior Pharmaceutical Quality Engineer is a technical professional that participates in the development, implementation, and evaluation of processes, procedures, and applications with the overall objective of providing Quality oversight for routine manufacturing of aseptically filled, radiopharmaceutical products produced by Contract Manufacturing Organizations (CMO.
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Our research programs encompass a broad range of biomedical research activities and areas of study, focusing on various fields such as cardiovascular disease, alcoholism, hematopoietic cancer, behavioral research, aging, and gene therapy.
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Serve on department, campus, and university committees as assigned (e.g., IACUC, IBC). Review IACUC and IBC protocols and provide post-approval monitoring. Position Summary Clinical Veterinarian The Laboratory Animal Resource Center (LARC) at a prestigious institution is seeking a customer service-oriented individual to join our team as a clinical laboratory animal veterinarian and Assistant Director.
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Able to perform all specialized imaging procedures such as angio, complex vascular and nonvascular interventional and therapeutic procedures, along with assisting the Radiologist/PA.Ensure all activities comply with regulatory agency standards.
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The Qualified Medication Aide sets up, administers, and records certain prescribed medications for residents in the facility under the supervision of a licensed nurse and as allowed by State regulatory agencies.
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The Vice President works closely with the Senior Vice President of Workforce and Careers, the Provost/Senior Vice President of Academic Affairs, campus Vice Chancellors of Academic Affairs, applicable curriculum committees, Sector Vice Presidents focused on Information Technology, Business, Logistics and Supply Chain, Entrepreneurship and Healthcare, and the Vice President of Career Link to ensure the College is providing academic offerings and training aligned to the needs of employers.
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Maximus will comply with regulatory minimum wage rates and exempt salary thresholds in all instances. Work with Section 508 Compliance Tester to design and execute comprehensive accessibility web testing by using a broad range of tools, including but not limited to Web accessibility tool bar (WAT), Axe, FireEyes, JAWS, NVDA, WAVE, ZoomText, WindowEyes, Dragon Naturally Speaking, - Create accessible documents using standard software such as Adobe Professional, Microsoft Word, Microsoft Power Point, and Microsoft Excel.
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regulatory affairs jobs Company: Rr Usa Inc in Indianapolis, AK, West Virginia
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