Associate Director, Regulatory Business Systems & Capability Strategy Boston, Massachusetts Category: Regulatory Affairs

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use.  I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionObjective / 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 qualityAccountabilities:                                                                                                                                                                                                  ·       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 & ExperienceBachelor’s degree required; advanced degree preferred8–12+ years of experience in Regulatory Affairs or related domainExperience working with regulatory systems (RIM preferred)Experience supporting cross-functional initiatives and requirements-driven deliveryTechnical CompetenciesStrong understanding of regulatory processes and lifecycle activitiesRequirements elicitation, analysis, and documentation expertiseUnderstanding of system capabilities, data structures, and process integrationAbility to translate business needs into structured and actionable requirementsBehavioral & Leadership CompetenciesStrong collaboration and stakeholder engagement across business and technology teamsExecution-oriented with focus on quality and delivery outcomesAnalytical thinking and structured problem-solvingClear communication and facilitation skillsContinuous improvement mindset with learning agilityAbility to operate effectively within a global, matrixed environment Takeda Compensation and Benefits SummaryWe 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, MAU.S. Base Salary Range:$154,400.00 - $242,550.00The 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 StatementTakeda 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.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob ExemptYesIt 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.