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Drive continuous improvement by recommending, planning and implementing process changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global Regulatory Project Management and Strategic Planning (RPM&SP) head.
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Join Takeda as an Associate Director, Global Regulatory Project Management and Strategic Planning - Neuroscience where you will partner with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to ensure global regulatory project plans for program / product of medium complexity are established and maintained, and plans & directs the seamless execution of the GRT goals.
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Significant experience in global drug development regulations, regulatory submissions, lifecycle management, compliance, business systems technology and process is required. As Associate Director, Global Regulatory Project Management and Strategic Planning, you will partner with the program Global Regulatory Lead (GRL), co-lead and facilitate product-specific Global Regulatory Team (GRT) meetings and cross-functional submission working groups (SWG) meetings, to oversee, plan and deliver GRT goals and regulatory submissions in accordance with regulatory strategy for moderately complex programs and submissions.
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Understanding of scientific principles and regulatory standards/requirements relevant to global drug development and post-market support. Ensure seamless alignment of operational plans with Global Project Management (GPM) team and Therapeutic Area Units (TAUs)/Business Units (BUs) asset strategies.
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Drive decision-making processes and escalate issues, as needed, ensuring proactive planning is taking place to enable delivery of all regulatory milestones for assigned programs. Elevate high-impact business critical issues and potential critical issues together with proposed plan of action, as appropriate, in a timely manner to GRL and management.
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At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. You will also lead cross-functional project submission working groups (SWG) to deliver successful submissions/filings and outcomes with Health Authorities (HA) for early to late-phase programs by providing effective Project Management leadership, oversight, direction and planning.
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U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. Advanced education or credentialing in regulatory affairs and project management preferred.
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This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy. You will report to Director, GRO Regulatory Project Management and be a part of the Global Regulatory Affairs Team.
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The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. Prepare and deliver reports and metrics on major regulatory milestone status, potential critical issues, constraints, bottlenecks, regulatory risks, mitigation management (and proposed solutions to support decision-making) for assigned programs.
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Proactively lead teams to identify and recommend solutions to problems and pathways to overcome timeline concerns and barriers for strategy execution. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
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U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
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Expertise with project management related software and tools (e.g. MS Project, OnePager, Office Timeline, SharePoint etc). We understand compensation is an important factor as you consider the next step in your career.
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Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. You will directly support program GRL by ensuring project management and regulatory operational support for the asset is effective, seamless and delivering to expectations.
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U.S. based employees may be eligible for short-term and/ or long-term incentives. Develop and maintain integrated regulatory project plans and integrated SWG plans. Liaise and proactively engage with third party stakeholders to ensure smooth, effective and timely work flows.
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At least one major (original or supplement) and several minor (amendment) filing experiences in one or more jurisdictions, along with eCTD experience is preferred. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
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strategic planning business development jobs Company: Takeda Pharmaceuticals
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