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May develop Standard Operating Procedures (SOPs) and Work Instructions (WIs) as directed by the Senior Director CMC Regulatory Affairs. Prior pharmaceutical industry experience and a minimum of 8 years in CMC Regulatory Affairs for Associate Director.
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Requirements: BSc or MSc level degree preferably within the life sciences (PharmD, PhD preferred) Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred) Prior experience of direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA) A solid understanding and experience in drug development including early and late development is highly preferred.
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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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Reporting to the Director of Regulatory Affairs, the Senior RA Specialist will collaborate with global team members, cross-functional teams, and stakeholders. JOB DESCRIPTION Job TitleSr. Regulatory Affairs Specialist-CT/AMIJob DescriptionThe Senior RA Specialist will play a critical role in ensuring Philips Computed Tomography (CT) and Advanced Molecular Imaging (AMI) solutions are safe, reliable, and compliant through driving global regulatory strategy and regulatory roadmaps—understanding competitive claim landscape, legislative initiatives, and marketing strategy.
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Demonstrate knowledge of credit underwriting, Trade Service and Trade Finance operations, BSA/KYC/AML, Factoring and Supply Chain Finance. Instruct back office on policy and procedures for new factoring and supply chain finance products.
$65,000 - $150,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Collaborate closely with cross-functional teams, including Supply Chain, Manufacturing, Quality Assurance, Clinical Operations and Regulatory Affairs, to ensure alignment and integration of logistics activities with overall business objectives.
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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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We are looking for a self-motivated and technically proficient Supply Chain Manager to work in our INTEX Millwork Solutions plant in Mays Landing, NJ. The Supply Chain Manager will be responsible for the strategic level and day-to-day activities needed to ensure that the company can consistently deliver our products to our customers in a manner and timeframe that they find desirable.
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The Supply Chain Specialist operates under the supervision of the Supply Chain Manager and/or Supply Chain Supervisor Perioperative Services: a member of the Perioperative Services department’s SCM team.
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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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Collaborate with key stakeholders and cross-functional partners (Development, Safety, Regulatory Affairs, HEOR, Medical Affairs, Precision/Molecular Medicine, and Genetics Research Center) to propose and execute on epidemiology and RWE studies that support key asset strategy needs.
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The Manager of Regulatory Affairs at AES Clean Energy (AESCE) will be tasked with supervising AESCE's positions and fostering relationships within the Federal Energy Regulatory Commission (FERC), managing policy positions within Regional and Independent Transmission Organizations (RTO/ISO), and taking the lead on filings and policy positions at state Public Utility Commissions (PUC) or Public Service Commissions (PSC) in key states.
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Act as the supply chain representative of the plant management team to support and execute plant initiatives, including SQF, HACCP, and food defense programs. He/she will also play a key role in the development of the supply chain roadmap and deployment of best practices in Nampa and throughout the MOM Group organization.
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As a Functional Supply Planning Manager, you will work hands-on to define optimal total supply chain solutions, develop financial impacts, and utilize a variety of systems to achieve goals.
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This role resides within Cresco’s Shared Services organization, reporting to VP Supply Chain, and will have visibility and accountability across the enterprise. Cresco Labs is seeking a Supply Chain Manager who will focus on enterprise material management, inventory warehouse systems, and a variety of other supply chain initiatives.
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regulatory affairs supply chain jobs Title: director government affairs
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