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Provide AZ technical functions with clear, concise guidance on current CMC regulatory requirements to support business tactical strategic planning. Direct Regulatory Affairs CMC experience, ideally in a development environment.
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The Associate Director of Regulatory Affairs Labeling will assist in the development of a cross-functional labeling strategy for products worldwide, including providing expert input on labeling requirements and strategic guidance during label development, facilitating cross functional labeling discussions with Labeling Management Team and Executive Labeling Committee as appropriate, and participating in label-related Health Authority negotiations.
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The Associate Director, Regulatory Affairs will establish and grow internal CMC regulatory activities, providing strategic management and content plans to support Vyriads gene therapy product development, registration, and post-approval strategies.
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Bachelors degree from an accredited institution with a focus in Chemistry, Pharmaceutics, or Biology preferred, and eight (8) years of technical experience in the pharmaceutical industry dealing and least three (3) years in CMC regulatory affairs.
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In collaboration with campus partners such as the General Counsel and the Associate Dean of Faculty Affairs, provide guidance to search committees in adhering to institutional policies and legal requirements throughout the search process, while also outlining standard search timelines and processes to maintain consistency and efficiency in recruitment.
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Role Title: Senior Manager/Associate Director, Regulatory Affairs CMC. Provide CMC regulatory guidance and support to internal teams including manufacturing/MSAT, Quality Assurance, and R&D.
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Software Guidance & Assistance, Inc., (SGA), is searching for a Regulatory Affairs Associate for a FULL-TIME assignment with one of our premier Pharmaceutical Services clients in Westchester County, NY. We have openings, one Associate Director level and one Associate level.
$82,000ExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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You will be responsible for providing, scientific leadership, and collaborative working environment to advance the drug candidates from IND through Phase IV. In addition, this position will collaborate with cross-functional stakeholders including in vitro & In vivo pharmacology, clinical biomarkers, DMPK, clinical development and operations, regulatory, CMC, and medical affairs.
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Associate Director/Director of Regulatory Affairs, CMC & Regulatory Sciences will be responsible for providing regulatory guidance to (Bio)Pharma product development, especially biosimilars, preparing and reviewing submissions.
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The Regulatory Affairs Associate will work on ensuring product formulations and claims are compliant with US FDA, Health Canada, and EU Food for special medical purpose ( FSMP ) regulations as well as Ajinomoto quality guidance.
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Regulatory Affairs Associate Abbott Park, IL. Job Summary: As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.
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Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP). Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial.
Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Experience in IVD Regulatory Affairs preferred. Knowledge of FDA PMA guidance documents and CFR regulations. Author and submit PMA supplements, including 30-day Notice, Real-Time Reviews, 180-Day Supplements, and Annual Reports.
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The Associate Director of Regulatory Affairs & Compliance position at IBSA Pharma Inc. will have primary responsibility for the oversight and management of Regulatory matters related to IBSA commercial and development product portfolio.
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Reporting to the Senior Associate Dean for Clinical Affairs with a dual reporting line to the Chief Financial Officer in the College of Dental Medicine, the Assistant Director of Supply Chain Operations will manage overall clinical supply chain operations to promote safe, efficient, and effective patient care ensuring the supply chain practices adhere to regulatory compliance regulations to minimize risk and align with and support the College of Dental Medicine initiatives.
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