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In this role, you will provide leadership and advice on the development of optimum regulatory strategies for drug development, product lifecycle management and portfolio management, particularly focused on emerging biopharmaceutical company customer goals in oncology.
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Thorough understanding and working experience in drug product development and manufacturing with respect to GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements.
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Solid knowledge of product life cycle management and understanding of scientific principles and regulatory CMC requirements relevant to global drug development. Associate Director, Global Regulatory Affairs, CMC Authoring (Remote.
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Join Takeda as an Associate Director, Global Regulatory Affairs CMC - Marketed Products where you will be a GRA CMC member on Regulatory, Pharmaceutical Development, and Commercial project teams throughout commercial lifecycle.
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As the Associate Director-Capital Procurement, you will play a pivotal role in planning, sourcing, and driving strategies related to drug product, device assembly, packaging, and robotics equipment.
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The Executive Director of Advertising & Promotion- Regulatory Affairs prescription drug products manages and, if required participates in, the reviews and approvals of advertising and promotional labeling pieces for prescription drugs.
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Today, Invicro's multi-disciplinary team provides solutions to pharmaceutical and biotech companies across all stages of the drug development pipeline (Phase 0-IV), all imaging modalities and all therapeutic areas, including neurology, oncology, and systemic and rare diseases.
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Headquartered in Boston, MA, Invicro was founded in 2008 with the mission of improving the role and function of imaging in translational drug discovery and development across all therapeutic areas.
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A thorough understanding of the drug development process from pre-IND through registration and post-registration and a broad understanding of functional areas of drug development, including (preclinical, regulatory, pharmacology, translational medicine, pharmacovigilance, data sciences (data management, biostatistics, programming), and clinical operations is require.
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This position will report to the Regional Sales Director. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices, peripheral stents, thrombectomy catheters and atherectomy devices.
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Strong understanding of pharmacokinetics, biomarkers, statistical principles, and regulatory requirements and demonstrated experience integrating these disciplines in the context of drug development.
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Serve as a strategic partner for data-driven workforce planning and development, employee engagement, and staff development/learning, DEIB. Will also play a key role in helping to strategically align with other constituents such as the Yale New Haven Hospital (YNHH) and Health System (YNHHS) on key HR initiatives that can bring synergy and best practices where appropriate.
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The successful candidate will have hematology/oncology clinical drug development experience, demonstrated leadership, and be able to critically navigate the science that underlies these programs.
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As needed, initially inspect, and reinspect Housing Choice Program properties (example-Section 8) annually for compliance with all applicable regulations and policies, including those of Housing and Urban Development (HUD) and the citys Housing Quality Standards (HQS) local building codes and zoning ordinances.
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Under the direction of the Sports Director or Coordinator, the Sports Monitor will monitor sports programs. As a thought-leader and best-in-class provider in education, wellness, youth development, and community-building, The YMCA of Metro Atlanta is one of the oldest and most essential non-profits serving in Atlanta.
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