Associate Director, Regulatory Business Systems & Capability Strategy

Posted Yesterday
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Boston, MA, USA
Hybrid
154K-243K Annually
Expert/Leader
Healthtech • Software • Analytics • Biotech • Pharmaceutical • Manufacturing
Takeda exists to create better health for people, brighter future for the world.
The Role
Supports regulatory capability strategy by developing roadmaps, prioritizing system enhancements, eliciting and documenting requirements, facilitating cross-functional workshops, and translating regulatory needs into scalable system capabilities. Partners with business, process, and technology owners to improve regulatory processes, data quality, compliance, standardization, and delivery execution across a global matrixed environment.
Summary Generated by Built In

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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.

LocationsBoston, MA

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull 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.

Skills Required

  • Bachelor's degree
  • Advanced degree
  • 8-12+ years of experience in Regulatory Affairs or a related domain
  • Experience working with regulatory systems
  • Experience with Regulatory Information Management systems
  • Experience supporting cross-functional initiatives and requirements-driven delivery
  • Strong understanding of regulatory processes and lifecycle activities
  • Expertise in requirements elicitation, analysis, and documentation
  • Understanding of system capabilities, data structures, and process integration
  • Ability to translate business needs into structured and actionable requirements
  • Strong collaboration and stakeholder engagement skills across business and technology teams
  • Analytical thinking and structured problem-solving skills
  • Clear communication and facilitation skills
  • Ability to operate effectively in a global, matrixed environment

Takeda Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Takeda and has not been reviewed or approved by Takeda.

  • Retirement Support — Employer-funded retirement is described as notably strong, combining a dollar-for-dollar 401(k) match with an additional company contribution that scales with age and service. Access to an employee stock purchase plan further supports long-term wealth building.
  • Parental & Family Support — Paid bonding leave for all parents, substantial adoption/surrogacy reimbursement, and robust caregiver resources (backup care and Maven family-forming support) are emphasized as core strengths. These offerings create a comprehensive safety net for a range of family situations.
  • Healthcare Strength — Multiple medical plan options (nationwide PPO/HSA and regional HMOs), employer HSA funding, and integrated mental-health and well-being programs signal depth in coverage. Preventive care is covered in-network, and plan choices by state expand access.

Takeda Insights

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The Company
HQ: Cambridge, MA
50,000 Employees
Year Founded: 1781

What We Do

For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation, and as a future-focused organization, we’re continuing to drive forward with endurance in our steadfast pursuit to achieve the best outcomes for our patients in a rapidly changing world.  We have been preparing for this period of value creation by investing in data, digital and technology, and we’re proud of our employees and their commitment to turning groundbreaking ideas into life-changing impacts.   Since our founding in Japan, integrity and putting patients first have been at the heart of our identity, and we will emerge ready for our future as one of the most trusted and science-driven digital biopharmaceutical companies. Join a team where your innovation impacts lives.   Together, we’ll realize improved outcomes by improving data quality, enhancing launch execution and improving the patient journey. You’ll play a critical role in accelerating data collection and increasing accuracy across all parts of the business. Patients across the globe will benefit from access to treatments afforded by greater opportunities and efficiency in our research and development.  

Why Work With Us

We connect to our history and Japanese heritage through everything we do to bring our purpose, values, vision, and imperatives to life. We are committed to bringing better health and a brighter future to patients. Being a part of Takeda means having the opportunity to be a part of something bigger than yourself.

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