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To do these effectively, the Analyst III – Policy & Regulatory Operations must have a demonstrated understanding of IEHP business operations and responsibilities of various departments in Health Services, Quality Systems, Provider Services, and Member Services; subject matter expertise of these departments’ policies and procedures and the regulations that drive their business operations and demonstrated ability to effectively and consistently manage multiple projects and priorities concurrently.
$80,059.2 - $106,059.2 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Job DetailsThe Director of Risk Management and Regulatory Affairs (Patient Safety Officer/Privacy Officer) serves as an accessible resource to the hospital and community on risk management and regulatory issues.
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The Senior Director, QARA is principally responsible for the development and implementation of the Company's quality assurance program through the development and implementation of quality assurance and compliance standards via policies and procedures, training, auditing and monitoring, facilitating internal reporting, compliance-related investigations, and keeping Third Party Logistics VP of Quality Assurance & Regulatory Affairs informed on quality assurance and regulatory affairs matters.
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The Senior Director, Quality Assurance and Regulatory Affairs (QARA) collaborates to set policy and procedures and then audits/monitors quality assurance. The Senior Director, QARA and his or her designees have the authority to review all documents and other information that are relevant to quality assurance and regulatory affairs activities.
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Join Takeda as a Director, Regulatory Affairs Vaccines CMC where you will provide program leadership and develop CMC regulatory strategy for global vaccine programs in various stages of development.
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Block is looking for an experienced policy and regulatory strategist to serve as our Head of Regulatory Affairs. Maintain fluency on a variety of regulatory and policy issues at the intersection of financial and technology policy, including financial regulation, consumer protection, tax, cryptocurrencies, AI/machine learning, intellectual property, and privacy.
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The Director, Federal Regulatory Affairs will report to the Managing Director, Federal Regulatory Affairs and will provide centralized management of Constellations advocacy at the Federal Energy Regulatory Commission (FERC) and other organizations, as appropriate, including all communications with FERC, internal development of positions, participation in proceedings, preparation and filing of pleadings, and informal advocacy.
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If so, this Director of Regulatory Affairs, CMC could be an exciting opportunity to explore. Our work spans all formulation types, novel technologies, and multiple modalities for small and large moleculesThe Director will lead key, strategic CMC regulatory activities for investigational and/or early commercial biopharmaceutical products.
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A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 15 years with a BA/BS, MA/MS, PhD or PharmD. Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development.
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OPPORTUNITY Mammoth is hiring a Director/Sr. Director, Regulatory Affairs, Therapeutics, to lead the regulatory activities of our growing CRISPR-based therapeutic programs as we bring them from concept to market.
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Regulatory and QA Specialist Our client is a highly regarded manufacturer of flavors and essential oils. Responsibilities Prepare regulatory documentation for flavors and essential oil products - SDS, Allergen statement, Natural status, GMO, Prop 65, flavor product Ingredient listing, etc.
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Bachelor's degree in life science and 10+ years of experience in regulatory affairs in the pharmaceutical/biotech industry. Regulatory expertise in project leadership, preferably negotiation with and conduct of meetings with the FDA and successful preparation and submission of IND/CTA/MAA/NDA/BLA with explicit CMC focus for biologics and/or small molecule modalities.
$167,000 - $241,925 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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A thorough understanding of the complex Regulatory, Development and Medical Affairs requirements in oncology, as well as the emerging paradigm for cell & gene therapy. Precigen is advancing an exciting pipeline of novel cell and gene therapy products and to further our efforts we are seeking an Executive Director, Medical Affairs who will be instrumental in creating and building the global medical affairs function at Precigen for our first commercial launch.
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Minimum of 10 years of experience within Regulatory Affairs (Oncology experience preferred) As a key member of the Regulatory Affairs leadership team, you will play a critical role in ensuring compliance with global regulations and driving the growth of our company.
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As SIRUM's first Legislative Affairs Director, you'll lead SIRUM's policy efforts across the country and be an integral part of shaping new drug donation policies nationwide. You have 3-5+ years of experience in legislative affairs, government affairs, and/or public policy (prior experience in healthcare or pharmaceutical policy strongly preferred.
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Title: director regulatory affairs Company: Kiniksa Pharmaceuticals Ltd
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