Associate Director, Regulatory Systems & Capabilities

Takeda Pharmaceutical Co.; Cambridge (MA); On-site; USD 154,000 - 243,000; Full time

Job summary

Takeda Pharmaceutical Co. is seeking an Associate Director to drive regulatory business systems and capability strategy from Boston, MA. You will translate regulatory needs into scalable system capabilities, align stakeholders, and enable structured requirements for efficient, compliant delivery.

Your background in Regulatory Affairs and experience with regulatory systems will help shape roadmaps, manage demand, and foster process improvements across global teams.

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.

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.
• 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.

Skills

Requirements elicitation

Requirements analysis

Documentation

Regulatory systems knowledge

Stakeholder collaboration

Process modeling

Education

Bachelor’s degree

Advanced degree preferred

Job description

Takeda Pharmaceutical Co. is seeking an Associate Director to drive regulatory business systems and capability strategy from Boston, MA. You will translate regulatory needs into scalable system capabilities, align stakeholders, and enable structured requirements for efficient, compliant delivery.

Your background in Regulatory Affairs and experience with regulatory systems will help shape roadmaps, manage demand, and foster process improvements across global teams.