Associate Director, Regulatory Business Systems & Capability Strategy

Takeda • Boston, MA

19d • $154,400 - $242,550

About The Position

The Associate Director, Regulatory Business Systems & Capability Strategy supports the definition and execution of regulatory capability strategy within GRIDS. The role partners with Business System Owners and Business Process Owners to translate regulatory needs into scalable system capabilities and ensure alignment across business, process, and technology. As a key contributor to capability initiatives, the position enables structured requirements definition, cross-functional alignment, and consistent delivery of regulatory system enhancements that improve efficiency, compliance, and data quality.

Requirements

• Bachelor’s degree required.
• 8–12+ years of experience in Regulatory Affairs or a related domain.
• Strong understanding of regulatory processes and lifecycle activities.
• Expertise in requirements elicitation, analysis, and documentation.
• Understanding of system capabilities, data structures, and process integration.
• Ability to translate business needs into structured and actionable requirements.
• Strong collaboration and stakeholder engagement across business and technology teams.
• Execution-oriented approach with focus on quality and delivery outcomes.
• Analytical thinking and structured problem-solving.
• Clear communication and facilitation skills.
• Continuous improvement mindset with learning agility.
• Ability to operate effectively within a global, matrixed environment.

Nice To Haves

• Advanced degree.
• Experience working with regulatory systems, with RIM preferred.
• Experience supporting cross-functional initiatives and requirements-driven delivery.

Responsibilities

• Support development and refinement of regulatory capability roadmaps aligned to GRA priorities.
• Partner with Business System Owners to structure and prioritize demand, backlog, and enhancements.
• Elicit, document, and refine business requirements, ensuring clarity, completeness, and alignment to regulatory needs.
• Facilitate cross-functional workshops with SMEs and Process Owners to define use cases and business scenarios.
• Translate business needs into structured requirements, supporting downstream design and delivery activities.
• Ensure consistency and reuse of requirements, capabilities, and design patterns across initiatives.
• Coordinate with Digital & Technology teams to support delivery and implementation of solutions.
• Identify opportunities for process optimization, standardization, and system improvements.
• Support adoption of best practices in capability modeling, requirements management, and delivery execution.

What This Job Offers

• Job Type: Full-time
• Career Level: Director