Associate Director, GRA Business Process Office

Takeda

10d • Remote

About The Position

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. 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. The Associate Director, Global Regulatory Affairs (GRA) Business Process Office (BPO) is a key contributor and business partner who supports continuous improvement, process optimization, and operational maturity efforts across the GRA organization. This role collaborates with GRA leadership, cross-functional teams, and cross‑enterprise stakeholders to facilitate the identification, design, implementation, and monitoring of scalable, compliant, and efficient regulatory processes by: Supporting the planning and execution of continuous improvement and process optimization activities Coordinating cross-functional teams to deliver successful project outcomes by providing expert and effective project management planning, leadership, direction, and oversight (partnering with key stakeholders in and outside of Global Regulatory Affairs) Coordinating and monitoring Regulatory operational support provided by internal and/or external resources Actively contributing to the identification and management of project budget and risk This role proactively supports business decisions, builds partnerships with key stakeholders, and helps embed regulatory priority into key business processes. By leading continuous improvement initiatives, applying Lean / Six Sigma and change management methodologies, and driving sustainable cross-functional adoption of improved ways of working, they contribute to advancing GRA’s operational effectiveness, compliance with Regulatory requirements and internal company standards, and alignment with strategic business goals.

Requirements

• Bachelor’s degree in Life Sciences, Business Administration, or related field (Advanced degree preferred)
• 7+ years of experience in pharmaceutical and/or biotech industry
• 4+ years of experience in Regulatory Affairs or drug development project management
• Working knowledge of Lean, Six Sigma, and continuous improvement methodologies
• Prior experience managing or contributing to a business process that leveraged KPIs and metrics as tools for monitoring performance and driving continuous improvement
• Prior experience in regulatory operations, business process management, continuous improvement, or related functions within a regulated industry (pharmaceuticals, biotech, medical devices, or similar).
• Demonstrated experience leading complex, cross‑functional continuous improvement or process transformation initiatives.
• Proven ability to influence without authority and partner effectively with senior leaders and cross‑functional stakeholders.
• Familiarity with regulatory systems, compliance frameworks, and quality control
• Excellent analytical, problem‑solving, strategic planning, stakeholder management, and communication skills.

Nice To Haves

• Lean Six Sigma certification (Green Belt, Black Belt, or equivalent) preferred.
• Experience operating within a Business Process Office, Center of Excellence, or PMO‑like structure preferred.
• Familiarity with regulatory systems, data, and digital tools that support process optimization preferred.

Responsibilities

• Operate within the established framework for standard GRA-wide architectural process documentation, process governance, and performance metrics to ensure consistency and continuous optimization.
• Assist process owners with the assessment of current‑state processes, identify inefficiencies, risks, and variability, and design future‑state solutions that are scalable, compliant, and sustainable.
• Provide best-practice guidance regarding process design, operational execution, and regulatory excellence.
• Support team members and stakeholder learning regarding continuous improvement principles and methodologies.
• With GRA process owners and key stakeholders, support efforts to embed continuous improvement mindset and capabilities.
• Apply Lean, Six Sigma, and continuous improvement methodologies (e.g., DMAIC, value stream mapping, root cause analysis) to identify and propose optimization strategies for end‑to-end Regulatory processes.
• Develop proposed execution plans for assigned initiatives.
• Lead complex initiatives within delegated scope.
• Ensure initiatives are delivered with clear scope, measurable outcomes, risk mitigation, and stakeholder alignment.
• Support the design and implementation of change management efforts that drive adoption of new or improved processes, tools, and ways of working.
• Partner with process owners to monitor key process performance indicators (KPIs) to measure effectiveness, efficiency, and compliance and recommend enhancements.
• Provide transparent and data-driven reporting to GRA leadership on improvement progress, risks, and realized benefits.
• Ensure alignment with GRA governance models, quality standards, and regulatory expectations.

Benefits

• 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees