Associate Director, Regulatory Business Systems & Capability Strategy

Regulatory Toolkit; Boston (MA); On-site; USD 154,000 - 243,000; Full time

Job summary

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.

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

Skills

Stakeholder engagement

Execution orientation

Analytical thinking

Communication

Problem solving

Global/matrix environment

Education

Bachelor’s degree

Advanced degree preferred

8–12+ years experience in Regulatory Affairs

Job description

Job Description

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.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.