Associate Director, Regulatory Business Systems & Capability Strategy

Objective / Purpose:

The Associate Director, Regulatory Business Systems & Capability Strategy supports the definition and execution of regulatory capability strategy within GRIDS. This role partners with Business System Owners and Business Process Owners to translate regulatory needs into scalable system capabilities, ensuring alignment across business, process, and technology.

Operating as a key contributor within capability initiatives, the role enables structured requirements definition, cross-functional alignment, and consistent delivery of regulatory system enhancements that improve efficiency, compliance, and data quality

Accountabilities:

· 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

Education & Competencies (Technical and Behavioral):

Education & Experience

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

Technical Competencies

Strong understanding of regulatory processes and lifecycle activities

Requirements elicitation, analysis, and documentation expertise

Understanding of system capabilities, data structures, and process integration

Ability to translate business needs into structured and actionable requirements

Behavioral & Leadership Competencies

Strong collaboration and stakeholder engagement across business and technology teams

Execution-oriented 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

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Boston, MA

U.S. Base Salary Range:

$154,400.00 - $242,550.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

For information about our benefits, please click here.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Employee

Regular

Full time

Job Exempt

Yes

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