Role at a glance
- Job function
-
Product, Strategy & Operations Business Analysis
- Salary
- Not yet verified Check the description for pay details; an amount or pay period has not been verified.
- Location
- Boston, Massachusetts, United States
- Employment
- Full-time
- Experience
- 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
- Education
- Bachelor’s degree required; advanced degree preferred
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Role Summary
The Associate Director, Regulatory Business Systems & Capability Strategy supports regulatory capability strategy within GRIDS, partnering with Business System Owners and Business Process Owners to translate regulatory needs into scalable system capabilities. The role supports aligned delivery of regulatory system enhancements intended to improve efficiency, compliance, and data quality.
What You'll Do
- 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, and facilitate workshops with SMEs and Process Owners to define use cases and...
- Translate business needs into structured requirements and coordinate with Digital & Technology teams on solution delivery and...
- Promote consistency and reuse of requirements, capabilities, and design patterns; identify opportunities for process optimization,...
Generated from the employer's posting. Verify important details before applying.
View full postingQualifications
Bachelor’s degree required. Requires 8–12+ years of experience in Regulatory Affairs or a related domain, experience supporting cross-functional initiatives and requirements-driven delivery, and expertise in regulatory processes, requirements elicitation, analysis and documentation, system capabilities, data structures, process integration, and translating business needs into actionable requirements. Also calls for stakeholder collaboration, analytical problem-solving, communication, facilitation, continuous improvement, and effectiveness in a global, matrixed environment.
Required
- Bachelor’s degree
- 8–12+ years of experience in Regulatory Affairs or related domain
- Experience supporting cross-functional initiatives and requirements-driven delivery
- 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
- Strong collaboration and stakeholder engagement across business and technology teams
Preferred
- Advanced degree
- Experience working with regulatory systems (RIM)
Original job description
Content provided by the employer
Original job description
Content provided by the employer
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 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, MAU.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, MAWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeJob 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.About the company
Takeda
Large Enterprise
Takeda is a global biopharmaceutical company headquartered in Tokyo, Japan, with a rich history spanning over 240 years. Specializing in the research, development, and commercialization of innovative medicines, Takeda focuses on therapeutic areas such as oncology, gastroenterology, neuroscience, and rare diseases. Committed to improving patient outcomes, the company harnesses advanced technologies and scientific expertise to deliver breakthrough therapies and enhance healthcare worldwide. Takeda's dedication to sustainability and social responsibility underscores its mission to strive towards better health for people and communities across the globe.