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Develop/implement effective CMC regulatory strategies for global submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks. Provides CMC regulatory guidance to manufacturing and quality teams; evaluates CMC change controls.
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In this role, you will be primarily responsible for handling regulatory affairs requirements for medical devices and biologic and products, including Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps.
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Support development of CMC regulatory strategies for submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks. Provides interpretation of regulatory guidance documents, regulations and directives advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs.
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Hello I'm Komal from Intellectt we have an opening for a Regulatory Affairs Specialist III in Mansfield, MA. Role: Regulatory Affairs Specialist III. Serves as the Regulatory Affairs lead on cross-functional MDR project teams.
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SUMMARY: This role will support the Business Development & External Affairs team with daily tasks, communications support, community outreach initiatives, event day operations and various other department initiatives, administrative tasks and special projects.
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The Head of Regulatory Affairs will lead the regulatory strategy and operations for a Point of Care business. Demonstrated success in Regulatory Affairs, including oversight or submissions for new products and product changes in Point of Care Diagnostics and with audits.
$224,616 - $308,847 a yearFull-timeExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
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Other administrative duties as requested or assigned by Casino Regulatory Managers and Compliance Coordinator. With guidance from the Casino Regulatory Manager and the Casino Compliance Coordinator, this position will be responsible for the oversight of the day-to-day internal operations of the Gaming Agents Unit at the licensed gaming facility.
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Strong knowledge of current US CMC regulations, including CTD format and content of CMC regulatory submissions, Knowledge of and broad experience with regulatory procedures and legislation related to CMC aspects of drug development, product registration, and post-approval lifecycle management (LCM.
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Under the supervision of the Director or Assistant Directors of Intercultural Affairs, students will develop skills and competence in these areas as well as learn more about the Stonehill College community.
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15+ years' experience in biotech or pharma with 10+ years in Regulatory Affairs. Experience with filing Orphan Drug Designations (ODD), FastTrack, Breakthrough Designations (BTD) and Priority Medicines Initiatives (PRIME) and other accelerated regulatory pathways ideal.
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The successful manager will be an active member of the Regulatory Affairs leadership team and manages department activities with responsibility for results in terms of costs, timing, methods and employees.
$130,000 - $145,000 a yearExpandApply NowActive JobUpdated Today
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