Associate Director, Regulatory Business Systems & Capability Strategy

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

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)

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.

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 Yes

It 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.

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own. Takeda is an equal opportunity employer.