Director, Global Regulatory Affairs Process Excellence and Transformation

The Director, Global Regulatory Affairs Process Excellence & Transformation leads complex, cross-functional operational excellence initiatives across Global Regulatory Affairs (GRA). The role is responsible for identifying, designing, and implementing process improvements that enhance efficiency, consistency, and quality across GRA processes. As a key member of the GRA Process Optimization Network (GPON), this role consults with cross-team representatives to diagnose operational challenges and deliver scalable, sustainable solutions. The Director applies deep subject-matter expertise and hands-on operational excellence experience to shape objectives and drive transformation aligned with GRA and corporate goals. This is a Boston based, hybrid position requiring 3 days/week onsite.

Key Duties & Responsibilities: 

• Lead complex GRA process improvement and transformation initiatives using structured operational excellence methodologies.
• Drive cross-functional consultation through GPON and partner with GRA sub-functions to identify, prioritize, and solve critical business process challenges.
• Define, standardize, and optimize end-to-end GRA processes, ensuring clarity, scalability, and alignment with organizational requirements.
• Facilitate process mapping, root-cause analysis, scenario planning, and solution development activities across GRA.
• Develop and implement change management plans, training, communication, and adoption strategies to ensure sustainable process implementation
• Partner with governance forums and senior leaders to ensure process improvements support GRA operational needs and corporate priorities.
• Create, maintain, and enhance process documentation including playbooks, workflows, templates, and RACIs. 
• Establish performance metrics, dashboards, and reporting to measure process health, adoption, and continuous improvement opportunities. 
• Collaborate across GRA, Program Leadership, and adjacent functions to ensure optimized processes integrate effectively across the development continuum. 
• Provide operational excellence coaching and capability building across GRA teams to strengthen process maturity and execution efficiency. 

Knowledge and Skills:

• Advanced knowledge of operational excellence methodologies and practical application of tools such as process mapping, root-cause analysis, value-stream mapping, and KPI development. 
• Strong expertise in developing and implementing process improvements across cross-functional teams. 
• Excellent written and oral communication skills, including the ability to facilitate workshops and present complex information to senior leaders. 
• Strong collaboration skills to effectively interact with internal and external stakeholders at all levels. 
• Ability to influence and drive alignment without formal authority. 
• Organizational skills and ability to manage multiple priorities. 
• Knowledge of regulatory processes, systems, and requirements is preferred. 
• Experience with digital workflow tools or process automation is a plus. 
• Ability to drive firm deadlines. 

Education and Experience:

• Minimally requires a Bachelor's degree in Life Sciences or a related field; an advanced degree is preferred.
• 10 years of experience or the equivalent combination of education and experience.
• Experience within the Life Sciences industry or similar.
• Hands-on experience applying operational excellence methodologies (e.g., Lean, Six Sigma, Kaizen) to deliver measurable process improvements.
• Experience leading large, complex, cross-functional process optimization efforts in a global or matrixed environment.
• Experience working with regulatory processes strongly preferred.