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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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Manage the bioanalytical assay transfer/validation, quality and conduct at external bioanalytical vendors and ensuring regulatory compliance. + Working knowledge of bioanalytical method validation and sample analysis regulatory guidelines in all regions (ICH, FDA, EMA, PMDA.
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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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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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Collaborate with Regulatory Affairs and Pharmacovigilance in the development of product labeling and periodic safety reports, as applicable. Purpose and Scope:The Medical Lead, Oncology, MUS (Medical Affairs-United States), is accountable for the development and execution of medical and scientific strategies for one or more products within the Therapeutic Area (TA.
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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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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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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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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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This investigation includes but is not limited to a criminal, civil litigations and regulatory review, employment, education, and credit review (role dependent). We welcome those with experience in jobs such as Accounts Payable Clerk, Accounting Manager, and Senior Accountant and others in the Accounting and Finance to apply.
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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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Responsible for working closely with the senior Anti-Money Laundering/Countering the Financing of Terrorism (AML/CFT) Officer to develop, administer and maintain an effective AML/CFT/Sanctions Compliance Program in accordance with applicable laws, guidelines and regulations.
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regulatory affairs jobs Title: affairs manager Company: Gpac in Mettawa, IL
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