Associate Director, Regulatory Systems & Capability

Regulatory Jobs; Boston (MA); Sur place; USD 154 000 - 243 000; Plein temps

Résumé du poste

Takeda seeks an Associate Director, Regulatory Business Systems & Capability Strategy to lead the definition and execution of regulatory capability roadmaps. The role partners with Business System Owners to translate regulatory needs into scalable system capabilities, ensuring alignment across business, process, and technology.

In Boston, you will drive cross-functional requirements, support delivery of reg system enhancements, and improve data quality and compliance through standardized

Qualifications

• Bachelor’s degree required; advanced degree preferred.
• 8–12+ years of experience in Regulatory Affairs or related domain.
• Experience working with regulatory systems (RIM preferred).
• Experience supporting cross-functional initiatives and requirements-driven delivery.
• Strong understanding of regulatory processes and lifecycle activities.
• Requirements elicitation, analysis, and documentation expertise.

Responsabilités

• 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

Connaissances

Stakeholder engagement

Execution orientation

Analytical thinking

Communication

Problem solving

Global/matrix environment

Formation

Bachelor’s degree

Advanced degree preferred

8–12+ years experience in Regulatory Affairs

Description du poste

Takeda seeks an Associate Director, Regulatory Business Systems & Capability Strategy to lead the definition and execution of regulatory capability roadmaps. The role partners with Business System Owners to translate regulatory needs into scalable system capabilities, ensuring alignment across business, process, and technology.

In Boston, you will drive cross-functional requirements, support delivery of reg system enhancements, and improve data quality and compliance through standardized