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You will lead a program focused on managing third party providers, import duty expense, customs classification, maintaining good standing and participation in programs with U.S. Customs and Border Protection, ensuring all U.S. and Canadian import compliance regulatory requirements are met and fostering a culture of integrity and ethical conduct throughout the organization.
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In collaboration with the Clinical Affairs Lead and Medical/Scientific Lead, prepares strategy decisions, presents, and discusses data at relevant team, governance, external consultants, KOL and potentially regulatory meetings.
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This position is ideal for self-starters with bank auditor experience, regulatory examiner experience or banking industry experience within risk management. Audit experience within Banking, Accounting / Consulting, Regulatory Agencies, or Financial InstitutionsCertified Internal Auditor (CIA) or willing to obtainAdditional Certifications:CRCM, CPA.
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Partner across functions to ensure robust systems in place to meet regulatory and stakeholder expectations in the areas of environmental compliance, product compliance, supplier conduct, and sustainability/ESG; support response to internal and external stakeholder information requests in these areas.
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Purpose Provides specialist medical and scientific strategic and operational input into core medical affairs activities such as: healthcare professional/provider interactions (HCPs, Patients and Payers); generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, data and value proposition); safeguarding patient safety (risk minimization activities / safety surveillance activities.
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The Regulatory Specialist will support the Legal and Regulatory Departments with monitoring and assessing the implications of existing and pending laws and regulations on RCP products and advocating for RCP's interests.
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The Manager of Statistical Programming must effectively interface with Statistics, Data Sciences, Medical Writing, Regulatory Publishing and Clinical Operations. In-depth understanding of the drug development process, including experience with regulatory filings.
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QUALIFICATIONSEducationBachelors Degree (± 16 years)In science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields are preferred or an equivalent combination of education and work experienceMasters Degree (± 18 years)PreferredDoctorate Degree (± 19 years) PreferredExperience/BackgroundMinimum 10 years Progressive work experience in regulatory affairs or a related discipline in the medical device field.
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Serves as AMC Liaison with executive leadership interfacing with continuum of care providers and public agencies including: SNF Administrators, vendors, CHHAs, LDSS-APS/CPS, NYS-OMH, OPWDD, MHLS among other regulatory agencies.
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Supply Chain Operations : Extensive techno-functional experience in supply chain operations including Demand Planning and Forecasting, Supply Planning and Inventory Optimization, Sales and Operations Planning, Procurement and Supplier Management, Network Optimization, Inbound Logistics and Transportation, Analytics and Reporting, Traceability, Recall and Regulatory Compliance Management.
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Inform Bank management and lines of business regarding changes to Federal and State regulatory law. Attend applicable regulatory training, seminars and conferences to maintain regulatory consumer compliance knowledge.
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Experience with pharmaceutical marketing principles and practices, including a demonstrated ability to develop strategic plans, conduct and interpret market research, and understand the regulatory environment.
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General Functions, Specific Responsibilities, and Authority:The Senior Quality Engineer works closely with shared functions (e.g. Regulatory Affairs, Designated Complaint Handling Unit (DCHU), Sterility Assurance, etc.
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Your teamAs a Principal Engineer at Baxter, you will provide Sterility Assurance leadership and technical support to multi-disciplinary product development teams, domestic/international manufacturing facilities, Regulatory Affairs and internal Sterility Assurance customers.
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At least 2+ years foundational experience as an IT Delivery Lead, Release Train Engineer or Agile Product Manager preferred. Join our Global IT Organization as we help shape the future through digital, data, and AI. We are looking for a passionate, dynamic, Agile Transformation Manager to define and lead Global IT’s Agile transformation journey and guide our organization and enterprise through a multi-year agile transformation and modern ways of working.
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regulatory affairs jobs Title: affairs manager Company: Gpac in Libertyville, IL
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