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Assist in the formulation of internal controls and policies to comply with legislation and established best practices. Coordinate the preparation of regulatory reporting. Oversee and manage the general accounting functions, including, but not limited to: accounts payable, accounts receivable, general ledger, and taxes.
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Maintain and improve processes and controls associated with manufacturing costs and inventory valuation. We are a leading player in the Medical Industry, is currently seeking a dynamic and experienced Accounting Manager to join our team.
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Experience with international product regulatory bodies and standardization organizations (e.g., Korea- KATS, Singapore-SFA, Middle East-GSO, Australia- ACCC) This entails a continuous vigilance over emerging global regulations related to consumer products for all regions of distribution, and the formulation of strategic compliance recommendations for leadership consideration.
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By ensuring regulatory changes are covered for global distribution channels. Socialize regulatory updates, impact, and compliance approach with internal and external partners through trainings and the publication of guidance documents.
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The Associate Director Biologics Quality Assurance will report to the Director of Biologics quality and will be part of a dedicated insulin team at our Civica Petersburg, Virginia state of the art formulation and filling facility.
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All Industrial Research & Development Laboratory related positions including: Formulation Chemist; Synthetic Chemist; R & D Leadership; Analytical Chemistry; Technical Service; Regulatory; Project Mangers; Process Chemistry; Environmental and Health; Quality Positions; Material Scientist.
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Masters degree in Pharmaceutical Science or related scientific field and minimum 8 years experience in pharmaceutical formulation and product development. PhD in Pharmaceutical Science or related scientific field and minimum 3 years experience in pharmaceutical formulation and product development.
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As a Research Scientist, the incumbent serves on multi-disciplinary scientific teams and provides technical guidance in research activities which generally include the characterization of drug products, its formulation and manufacturing process as it relates to drug delivery, in vitro drug release and in vivo drug performance.
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May have responsibility for planning, budgeting and policy formulation within area of expertise. Identifying, documenting, and escalating weaknesses within the workstream, including regulatory findings, internal audit findings, and self-identified issues.
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Author Analytical Development CMC sections of regulatory filings and respond to information requests as appropriate. Assume accountability for all Analytical Development CMC deliverables, including support of process and formulation activities.
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Highly experienced with cGMPs, FDA, EU, ICH guidelines and CMC regulatory submissions. Strong scientific expertise in development and commercialization of antibody co-formulation, and/or combination products.
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4 - 7 years’ experience in computer systems, business analyst with LIMS systems (Lab environment, Compliance oe Regulatory is required) Leads process improvements including, formulation and definition of technical scope and objectives of project, analysis of current business practices, processes, and systems, define detailed project tasks, and participating on a matrix team to execute projects.
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Assist in the formulation of validation/qualification protocols and summary reports, adhering to regulatory requirements and industry best practices. Oversee the review of HCT/P donor records to ensure final product release aligns with standard operating procedures and regulatory/accrediting agency requirements.
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Denison Pharmaceuticals is a leading provider of turnkey formulation, manufacturing and packaging solutions for the OTC, Cosmetic, Homeopathic and Pharmaceutical markets. The Internal and Supplier Quality Auditor, you will play a critical role in ensuring product quality, regulatory compliance, and continuous improvement within our organization.
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We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of synthetic psilocybin (which has received breakthrough therapy designation from the FDA) is administered with psychological support.
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