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New · posted Oct 22

Takeda · Pharmaceuticals

Associate Director, Regulatory Business Systems & Capability Strategy

  • Boston, MA
  • On-site
  • Full-time
  • Director
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EmploymentFull-time
Deadline

Open until filled

The role

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

What you need

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

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

Pay

$154,400 – $242,550 a year

Employer provided
How this compares

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.

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.

Where you'll work

Boston, MAOn-siteOpen in Maps (opens in a new tab)

More jobs in Boston, MA

Working conditions

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

About twenty smiling Takeda interns with name badges posed on a deck with the Boston skyline behind

From the posting

About Takeda

For Location

Boston, MA

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.

Takeda company page · 47 open roles
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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.

Job intelligence

The context around this role

Live data · October 23, 2026

Salary intelligence

How the pay compares

This role's midpoint is level with the US median for Regulatory Operations roles at this level.

This roleEmployer provided

$154,400 to $242,550 a year

Director roles in Massachusetts7 roles publishing pay

Middle half $198,500 to $213,750, median $198,500

Director roles in the US13 roles publishing pay

Middle half $182,000 to $200,500, median $198,500
Annual base pay
Annual base payLowMedianHigh
This role$154,400—$242,550
Massachusetts$198,500$198,500$213,750
All US$182,000$198,500$200,500

This role: Takeda's own published range. Comparisons: the base pay employers published on open Regulatory Operations roles at the same level on Regulatory Jobs, October 23, 2026. Nothing is estimated.

Career trajectory

Where this role sits in Regulatory Operations

The general path across 42 open Regulatory Operations roles on Regulatory Jobs, with the titles they carry most. Not Takeda's own promotion track.

  1. Earlier

    Associate & Specialist

    Often: Regulatory Operations Specialist · Associate Specialist, Regulatory Affairs Operations TMTT

    $80K median9 open
  2. Earlier

    Senior & Principal

    Often: Senior Associate, Regulatory Affairs Submission Management · Senior Associate, Regulatory Affairs

    $124K median6 open
  3. One step back

    Manager

    Often: Manager, Regulatory Operations · Senior Manager, Regulatory Operations

    $176K median13 open
  4. This role

    Director

    Often: Associate Director, Regulatory Business Systems & Capability Strategy · Associate Director, Regulatory Operations

    $199K median13 open
  5. Next step

    VP & Executive

    Often: Vice President, Head of Global Regulatory Operations

Skills DNA

What this role leans on

How many of the posting's 14 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

GMP and compliance: 1 lineLab testing and methods: 1 lineDocumentation and SOPs: 2 linesQuality systems and risk: 1 lineData and digital systems: 2 linesCollaboration and leadership: 5 linesGMPLab testingDocumentationQuality systemsData systemsTeamwork
  • Collaboration and leadership5
  • Documentation and SOPs2
  • Data and digital systems2
  • GMP and compliance1
  • Lab testing and methods1
  • Quality systems and risk1

Company hiring pulse

Takeda on Regulatory Jobs

47
Open roles
44
Distinct roles
16
Locations

By discipline

  • Regulatory22 47%
  • Quality18 38%
  • Compliance & Safety6 13%

By level

  • Director26 55%
  • Senior & Principal11 23%
  • Manager5 11%
See all 47 Takeda roles

More roles at Takeda

All 47 Takeda roles

Similar Regulatory Operations roles elsewhere

Associate Director, Regulatory Business Systems & Capability Strategy at Takeda

Open until filled. $154K–$243K a year, employer provided.

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