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Strong background with FDA cGXP standards and regulatory requirements for packaging and labeling. As part of this opportunity, the incumbent will work with functional groups including Regulatory Affairs, Quality Assurance, Marketing, Packaging and Manufacturing to develop requirements for labeling text.
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Work collaboratively with Regulatory Affairs and Research and Development regarding Product Development (Design) Controls, Design Assurance, and Labeling Control. Strong expertise in domestic and international regulatory compliance requirements (e.g. FDA QSR, ISO/EN standards, and MDSAP.
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Counseling clients on the Federal Food, Drug, and Cosmetic Act and FDA regulations and guidance documents, the Hatch-Waxman Act and associated regulatory exclusivities, product lifecycle planning, pediatric studies, post-marketing regulatory commitments, drug review and approvals, labeling and citizen petitions.
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Some labeling experience strongly preferredEducation/Experience:Bachelor's degree or equivalentMinimum of 1 year of relevant document control management experience in a cGMP/FDA regulated environmentWhat's In It For You.
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Execute and enforce Food Safety, HACCP, FDA, and labeling policies to guarantee compliance with industry standards. HACCP is required, PCQI Preferred. The QA Team Supervisor will report to the QA Manager and be responsible for overseeing the Quality Assurance team, ensuring compliance with all relevant regulations, and maintaining the highest standards for our products and processes.
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Experience leading internal audit programs and managing external inspections/audits (e.g. FDA, Competent Authorities, Notified Bodies) Responsible for Continuous Improvements of the BioLegend Quality Management System including: Management Review, Change and Document Control, Records Management, Validations, Audit and Inspection Management, Corrective and Preventive Action Management, Complaints, Failure Analysis, Risk Management per total product life cycle, Nonconformance Management, Distribution Quality, Supplier Quality, and Manufacturing Quality.
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The Vice President, Global Quality Assurance is responsible for establishing, monitoring, maintaining, and evolving the Quality strategies of the Sentry Group to align with applicable regulatory agency requirements (e.g. FDA, DEA, USDA, US CBP, and EMA; National Association of Boards of Pharmacy (NABP); US states’ boards of pharmacy; current GxPs), as well as client needs.
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Provide current and consistent legal advice related to laws, regulations and industry trends affecting Vir and the biopharmaceutical sector, including, for example, healthcare laws, trade compliance guidance documents and regulations, healthcare regulatory issues, healthcare fraud and abuse, pharmacovigilance, advertising and labeling, product liability, pricing and reimbursement, antitrust, privacy, and other matters relevant to investigational and commercial therapeutic products.
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The Surgical Specialist 2 will assist the Team Leaders, Team Leader 2s and, Tissue Recovery Supervisors in the operating room by preparing the body for surgery, prepping/draping, circulating, packaging, and labeling of tissue grafts in accordance with processor SOPs in preparation for shipment.
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Providing specialized legal support to Medical, Commercial and Regulatory teams on FDA regulations and enforcement on advertising and promotion. This position reports into the US Regulatory and Safety legal team, focusing primarily on US regulatory law matters with responsibility for interpreting and advising on the implementation of key FDrelated laws, regulations and policies, counseling the business regarding regulatory exclusivities, product lifecycle planning, pediatric studies, post-marketing regulatory commitments, generic and biosimilar market entry, and regulatory requirements associated with product labeling.
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Collaborate regularly with the Office of Ethics and Compliance, Medical Affairs, and Regulatory Affairs departments concerning a broad range of legal, regulatory and compliance issues, including FDA regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, industry codes such as AdvaMed and PhRMA, the Sunshine Act, Foreign Corrupt Practices Act, and competition law in connection with product labeling, promotional, and non-promotional activities.
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Command of relevant laws, regulations, guidance and industry codes governing healthcare products, regulatory aspects of healthcare products, healthcare fraud and abuse, pharmacovigilance, GMP, advertising and labeling, product liability, pricing and reimbursement, antitrust, privacy, and other matters relevant to the development and the commercialization of biotechnology and pharmaceutical products.
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Collaborate with Manufacturing Sciences, Tech Transfer and Validation team in developing, transferring, scaling and validating manufacturing processes, including formulation and dispensing, in accordance with company procedures, cGMPs, FDA and ICH guidelines.
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Possess clinical supplies experience/knowledge in forecasting, demand / supply planning, IRT systems, inventory management, clinical labeling and distribution including cold chain, import/export, and reverse logistics.
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Oversee that all in-line checks for count, labeling, seal integrity and overall package quality are monitored accurately and within designated times as slated in our SOP. Knowledge of FDA/cGMP guidelines.
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