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The applicant should join SPARC to take the leadership position for clinical regulatory affairs strategy in a dynamic and rapidly growing novel drug discovery company. The position is to provide regulatory affairs strategic leadership for SPARC and supported Sun novel drug development programs.
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As the SAP Business Analyst, you will support and manage SAP Product Lifecycle Management (PLM) and SAP Master Data Governance (MDG) capability supporting the Research, Development and Engineering (RD&E) and Global Safety and Regulatory Affairs (GSARA) teams.
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Manage accurate and timely safety related regulatory reporting (AEs, SAEs, UADEs) per study and regulatory requirements including collaboration with regulatory affairs and clinical operations, or overseeing activities of third-party managing safety reporting.
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Works with Sr. Director, CA Chief Lobbyist Affairs and member companies to develop and execute lobbying strategies related to issues pending and anticipated before the legislature and relevant agencies.
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Lead and work across a Cross Functional Matrix with both R&D internal partners including regulatory and scientific affairs, and functional, technical and commercial business leaders to create integrated plans and translate portfolio stewardship risks into transformation plans (including plans for risk mitigation of ingredients, creation of processing methods to address risks, to ensuring compliance and fit for purpose products in accordance with regulation.
$113,300 - $226,600 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Role Title: Senior Manager/Associate Director, Regulatory Affairs CMC. A minimum of 6-10 years in the biotechnology industry with 4-5 years in Regulatory Affairs CMC. An advanced degree and regulatory affairs certification are desirable.
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Experience 7-10 years pharmaceutical industry experience, including 3 years of experience in CMC Regulatory Affairs projects comprising biologic therapeutics. · Represents Regulatory Affairs activities among cross-functional project teams and functions as the primary contact on CMC regulatory aspects of the projects between Akston and its partner companies.
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Support regulatory filings by guiding the draft, review, and approval of CMC sections; support associated agency interactions and product-related inspections Partner with cross functional members across Gilead Pharmaceutical Development & Manufacturing (PDM), including Quality, Supply Chain, Manufacturing, Regulatory Affairs CMC, Finance and Technical Development to ensure successful commercialization of the late-stage portfolio, as well as on time delivery of clinical and commercial product.
$274,635 - $355,410 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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As part of the GRA CMC Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs, Pharmaceuticals. Join Takeda as a Director, GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA CMC Pharmaceuticals Oligonucleotide regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM stages.
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Regulatory Affairs Project Manager / Regulatory Affairs Manager (m/f/d) Lean Manager / Project Manager (m/f/d)Our offer:Attractive and fair salary conditions Extensive employee benefit programme “Orizon PlusPoints” Training measures suiting your tasks and activities.
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The Analyst II, Regulatory Affairs has experience with and performs key centralized complex and difficult regulatory activities for the Compliance Department. Knowledge of and experience with state and Federal regulatory and other requirements and practices related to Covered California, Medicare and Medi-Cal (Medicaid), Title 19 (USC)/Title 29 (USC and CCR), Title 22 (CCR), Title 28 (CCR), Title 42 (USC and CFR), CA Welfare and Institutions Code, and CA Health and Safety Code.
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Build the Regulatory Operations infrastructure and oversee development of standard operating procedures, training materials, and job aids with respect to Regulatory Affairs and Operations.
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Interface effectively with all other BMS internal stakeholders: Global Medical Affairs functions and other departments, including Commercial, Clinical Research and Development, Regulatory Affairs, Managed Care, Pharmacovigilance, Market Access, Statistics, Translational Research/Development, Project Leadership, etc.
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Responsible for approval of medical and scientific content of Regulatory, Safety, Scientific Affairs, Medical Affairs and Commercial outputs for assigned therapeutic areas. Board Certified in therapeutic area and US fellowship training, or MD with 2-4 years’ experience in within the pharmaceutical industry including 2 years in-house Medical Affairs role, or PhD or PharmD with 5 years’ experience within the pharmaceutical industry, including experience in the therapeutic area and 3 years in an in-house Medical Affairs role; MD preferred.
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Supports the Director, Regulatory Law, Government Affairs and Trade Compliance in managing risk within the defined scope of responsibility. Reports to: Director, Regulatory Law, Government Affairs and Trade Compliance.
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