Associate Director, Regulatory Systems & Capability Strategy

Takeda

Boston (MA)

On-site

USD 154,000 - 243,000

Full time

2 days ago

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Job summary

Takeda in Boston, MA is seeking an Associate Director, Regulatory Business Systems & Capability Strategy to lead the translation of regulatory needs into scalable system capabilities. The role partners with business system owners to align demands, roadmaps, and delivery across regulatory processes.

The candidate should have 8–12+ years in Regulatory Affairs, experience with regulatory systems (RIM preferred), and strong collaboration across global teams to drive process improvements and

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).

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.

Skills

Stakeholder collaboration

Requirements elicitation

Regulatory processes

Problem solving

Communication

Education

Bachelor's degree

Advanced degree

Tools

RIM software

Job description

The candidate should have 8–12+ years in Regulatory Affairs, experience with regulatory systems (RIM preferred), and strong collaboration across global teams to drive process improvements and

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