Associate Director, GRA Business Process Office
Takeda, Boston, MA, United States
Job Description
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.
About the Role 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.
Core Responsibilities
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.
How you will contribute
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.
Continuous Improvement Leadership
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.
Governance, Metrics & Reporting
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.
Qualifications
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.
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.
More about us At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best‑in‑class patient support programs. Takeda is a patient‑focused company that will inspire and empower you to grow through life‑changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. 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.
This position is currently classified as "remote" following Takeda's Hybrid and Remote Work policy.
Location and Compensation Massachusetts - Virtual
U.S. Base Salary Range: $153,600.00 - $241,340.00
EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
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About the Role 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.
Core Responsibilities
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.
How you will contribute
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.
Continuous Improvement Leadership
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.
Governance, Metrics & Reporting
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.
Qualifications
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.
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.
More about us At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best‑in‑class patient support programs. Takeda is a patient‑focused company that will inspire and empower you to grow through life‑changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. 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.
This position is currently classified as "remote" following Takeda's Hybrid and Remote Work policy.
Location and Compensation Massachusetts - Virtual
U.S. Base Salary Range: $153,600.00 - $241,340.00
EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
#J-18808-Ljbffr